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Clinical Data Scientist – Hybrid or Remote Overview A growing organization in the healthcare and life sciences technology space is seeking a Clinical Data Scientist to support the final stages of its clinical data pipeline. This role focuses on transforming complex clinical datasets into clean, standardized, analysis‑ready deliverables for use in clinical research and regulatory submissions. The ideal candidate is detail‑oriented, technically versatile, and passionate about delivering high‑quality clinical data. You will work closely with cross‑functional teams—including Clinical Operations, Data Platform Engineering, and AI/ML teams—to ensure accuracy, traceability, and compliance across all data outputs. This role may be hybrid or fully remote; candidates in the SF Bay Area are preferred but not required. Key Responsibilities Data Transformation & Delivery • Convert raw, manually abstracted, and AI‑processed clinical data into standardized formats (e.g., CDISC SDTM/ADaM) or client‑specific data models., • Build analysis‑ready datasets from diverse sources including EMRs, EDC systems, and internal abstraction tools. Statistical Programming & Reporting • Develop and generate Tables, Listings, and Figures (TLFs) for clinical study reports and interim analyses using SAS, R, or Python. Data Integrity & Quality Control • Perform comprehensive data cleaning and validation checks., • Investigate discrepancies to distinguish between true clinical complexity and upstream data errors. Cross‑Team Collaboration • Partner with engineering teams to automate data cleaning and validation workflows., • Serve as an early tester and internal customer for new data infrastructure tools. Documentation • Create and maintain clear documentation including data specifications, derivation logic, reviewers’ guides, and Define.xml to support audits and regulatory submissions. Ad‑Hoc & Exploratory Analysis • Support internal and external stakeholders with data queries, one‑off analyses, and insights that demonstrate the value of the platform. Ethical & Compliant Data Management • Follow all applicable privacy, security, and compliance requirements (e.g., HIPAA)., • Promote ethical handling of sensitive clinical data. Qualifications Education • BSc or MSc in Statistics, Mathematics, Computer Science, Life Sciences, or a related field. Experience • 2–5+ years in clinical data science, statistical programming, or clinical data management within Pharma, Biotech, or related environment. Technical Skills • Strong proficiency in SAS, R, Python, and SQL., • Familiarity with version control (Git) preferred., • Experience with CDISC SDTM/ADaM standards., • Understanding of oncology endpoints (e.g., RECIST, survival analysis) and real‑world data (RWD) is a plus. Core Competencies • Demonstrated expertise in cleaning and stitching complex datasets., • Ability to work with unstructured text or NLP‑derived outputs is highly desirable., • Exceptional attention to detail and accuracy., • Strong written and verbal communication skills., • Self‑directed, curious, humble, and collaborative. Additional Information • Travel: Up to 5%, • Compensation: Competitive salary range based on experience, qualifications, and location., • Eligible for equity, annual performance bonus, and comprehensive benefits.

About Us Kali Therapeutics embodies transformation and renewal, inspired by the Hindu goddess Kali, symbolizing power and rebirth. Focused on groundbreaking advancements in immunotherapy, Kali Therapeutics specializes in T-cell engagers and other innovative therapies that address high unmet medical needs. About The Role Reporting to the Chief Medical Officer, the (Associate/Sr) Director of Translational Medicine is responsible for leading translational and biomarker efforts across therapeutic portfolio with multiple biologics in therapeutic areas including autoimmune and oncology. You will help provide strategic and scientific leadership to define the translational vision, ensure biomarker‑driven clinical development, and integrate deep immunologic understanding into program strategy. You will also manage external vendors (e.g. CROs, biolabs) to ensure biomarkers’ assessments and data delivery from global clinical studies. You will serve as a translational science leader and will partner closely with Clinical Operations, Clinical Development, Drug Discovery, Regulatory, and CMC teams to ensure translational excellence and mechanism‑driven insights across the development lifecycle. You may also collaborate with external partners to develop and align translational strategies for clinical studies. What You'll Do: • Lead end to end translational biomarker strategy for clinical programs, ensuring biomarker driven clinical development aligned to program timelines., • Oversee development, validation, and implementation of biomarker assays, including immune monitoring, tumor biology assessments, and patient stratification tools., • Collaborate with clinical and medical leads to design and execute clinical trial design and biomarker strategies that advance mechanistic understanding and inform dose optimization and patient selection., • Act as the primary translational science lead on cross functional development teams, influencing clinical strategy through biomarker and mechanistic insights with clarity and scientific authority., • Drive scientific innovation and identify novel biomarker opportunities to support patient stratification, pharmacodynamics, resistance mechanisms, and combination therapy rationale., • Prepare and present clear, data driven presentations for internal leadership, key opinion leaders, regulatory authorities, and external collaborators., • Manage CROs responsible for assay development and execution, including scope of work, budget planning, audits, quality oversight, and performance management., • Oversee central lab operations and biospecimen management, ensuring compliant handling, storage, tracking, and availability of samples for translational analysis., • Build and maintain productive relationships with cross functional team members, key opinion leaders, investigators, and external partners, fostering a culture of collaboration, accountability, and scientific rigor. What You'll Bring: • PhD, or equivalent in Immunology, Oncology, Translational Medicine, or related discipline., • 5+ years of industry experience with increasing responsibility in translational medicine, biomarker development, or related fields., • Experienced in managing external CROs and vendors, and leading central lab operations and biospecimen management., • Strong working knowledge of GLP/GCP and biomarker related regulatory expectations, including contributions to clinical protocols, investigator brochures (IBs), IND, lab manuals, and clinical study reports (CSRs)., • Strong data analysis experience with biomarker endpoints and biological datasets, and proficiency with platforms such as Spotfire., • Excellent presentation and communication skills with a demonstrated ability to translate complex data into decisive recommendations and engage internal leadership, investigators, and external stakeholders., • Proven leadership in matrixed team environments with the ability to influence without authority and align scientific priorities across cross functional teams., • Comfortable operating in a fast moving, collaborative biotech environment. Kali is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. At Kali we engage in equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. We take care of our employees with a competitive benefits package that provides medical, dental, and vision coverage for employees and their dependents, as well as 401(k) plans.

AI Engineer 1) Organization Overview (Concise & Neutral) A fast‑growing oncology‑focused organization is reinventing how clinical trials operate by integrating them tightly with real‑world clinical practice. Cross‑disciplinary teams across healthcare, engineering, AI, and regulatory domains work in a Human‑in‑the‑Loop (HITL) model to deliver regulatory‑grade outcomes that expand trial access and accelerate cancer drug development. What’s Different • Clinical trials are embedded within clinical practice—not run in parallel., • Hybrid model blending expert abstraction, AI/NLP/LLMs, and EMR integrations., • Strong commitment to rigorous testing, validation, privacy, and ethical AI., • Mission‑driven culture with high collaboration and urgency. Why Join Now • AI is essential to scaling the business—impact is immediate and visible., • Opportunity to build an end‑to‑end applied AI stack powering clinical teams., • Work across LLMs, CV, and multimodal use cases with strong platform engineering partners. 2) Role Overview — AI Engineer Purpose Design and deliver applied AI systems (LLMs/CV/multimodal) that automate clinical variable extraction and clinical note generation. Work includes repeatable validation, robust documentation, and HITL feedback loops. Strong emphasis on data engineering and backend rigor to ensure model usability and efficiency. Focus Areas • LLM development and LLM‑Ops for text extraction and structuring; some CV/multimodal., • Rapid prototyping with high software‑engineering hygiene., • Statistical validation plans, experiment design, and metrics ownership., • HITL workflow development to reduce manual QA and improve throughput., • Collaboration with Platform Engineering for production alignment., • Comprehensive documentation: datasets, experiments, model cards, QA audits., • HIPAA‑aligned safeguards and compliant AI practices. Core Responsibilities • Build AI models and pipelines across EMR/EHR, imaging, and clinical documents., • Translate ambiguous clinical requirements into measurable ML objectives., • Define metrics, design experiments, and estimate/model error., • Lead interim QA audit processes and evolve toward AI‑assisted QA., • Partner with data/platform engineers on scalability, data flow, and observability., • Champion code quality, experiment tracking, reproducibility, and knowledge capture. Expected Impact (6–12 Months) • Deliver validated AI components for abstraction and note generation., • Meaningfully reduce manual QA workload through HITL optimization., • Standardize testing and documentation frameworks., • Establish efficient PySpark/SQL/Postgres data‑manipulation patterns that accelerate iteration. 3) Product & AI Context In‑Flight Work • LLM‑powered abstraction and clinical note generation with HITL., • Auditing and validation pipelines. Mandate • Drive productivity gains for internal labeling/abstraction teams., • Build the full applied‑AI stack: model development, context engineering, QA automation, interfaces. Productionization • Deployment owned by Platform Engineering, but AI Engineers write scalable, integration‑ready code. Data Gravity • Data engineering is a major part of the role: PySpark, SQL/Postgres, query optimization, cloud data tooling. 4) Ideal Candidate Profile Background • MSc/PhD in CS, EE, Applied Math, Stats, Physics, or equivalent depth via experience., • 2–5+ years in AI/ML engineering or applied data science., • Healthcare or clinical workflows experience strongly preferred; oncology a plus. Technical Must‑Haves • Expert‑level Python + strong software engineering practices., • Deep learning experience with PyTorch or TensorFlow (LLMs and/or CV)., • Data engineering: PySpark, SQL, Postgres, data modeling, query tuning., • Cloud data platforms (Databricks, S3/Snowflake/Azure/GCP)., • Experiment design, statistical validation, and error analysis., • HITL lifecycle design and feedback integration. Nice‑to‑Have • Additional languages: R, Java, C++., • MLOps fundamentals (versioning, lineage, CI/CD)., • Prior oncology or clinical trials exposure.

$35 - $100/hourpayEViewsMacroeconomicsAbout micro1micro1 connects domain experts to the development of frontier AI models. Real-world expertise is turned into training data, evaluations, and feedback loops that improve how models perform. AI labs and enterprises use micro1 to train models and build reliable AI agents through advanced evaluations and reinforcement learning environments. Experts contribute directly to how AI systems learn, reason, and perform across domains like finance, healthcare, engineering, and more. Our platform identifies and vets top talent through an AI recruiter, enabling high-quality contributions at scale.Our goal is to enable 1 billion people to do meaningful work by applying their expertise to AI. We’ve raised $40M+ in funding, and our AI recruiter has powered over 1 million AI-led interviews as our global network of experts grows into the human intelligence layer for AI. Job Title: Macroeconomic Modeling Specialist (EViews) Job Type: Contract Location: Remote Job Summary Join our customer's team as a Macroeconomic Modeling Specialist (EViews) and drive the creation, validation, and automation of advanced macroeconomic models. Leverage your expertise in EViews to develop robust time-series and forecasting solutions, contributing essential economic insights that inform key decisions at the organizational level. This remote opportunity is ideal for a passionate modeler who values clarity in communication and excellence in quantitative analysis. Key Responsibilities • Design and implement sophisticated time-series models such as VAR, VECM, ARIMA, and cointegration frameworks using EViews., • Conduct rigorous model diagnostics and validation to ensure robustness and reliability of forecasts., • Automate forecasting workflows for efficiency and scalability within the modeling process., • Translate complex statistical outputs into clear, actionable macroeconomic insights for both technical and non-technical stakeholders., • Document modeling approaches and results with precise, concise written reports., • Collaborate with the customer's team to integrate modeling results into broader economic narratives and policy recommendations., • Stay current with macroeconomic modeling best practices and EViews software updates. Required Skills and Qualifications • Extensive hands-on experience with EViews, including scripting and automation functionalities., • Proven expertise in building, estimating, and validating time-series models—especially VAR, VECM, ARIMA, and cointegration models., • Deep knowledge of model diagnostics, stability tests, and forecasting accuracy measures., • Strong quantitative background with the ability to explain complex modeling processes in clear written and verbal communication., • Demonstrated success in automating modeling and forecasting workflows., • Ability to extract economic meaning from statistical outputs and present findings insightfully., • Self-driven, detail-oriented, and adept at remote collaboration. Preferred Qualifications • Advanced degree in Economics, Econometrics, Applied Statistics, or related field., • Previous experience supporting central banks, policy institutions, or financial sector clients with macroeconomic modeling., • Familiarity with additional econometric software or programming languages (e.g., R, Python, Stata).

About the Role The role involves leading performance testing initiatives, managing teams, and ensuring the successful execution of performance test cycles for large-scale enterprise systems for one of our prestigious client. *The Candidate shall meet the qualifications below: • At least seven (7) years of experience performing performance testing or performance engineering for large scale enterprise systems as defined above., • At least four (4) years of experience in a lead role, managing performance testing teams, including planning, execution, and reporting of performance test cycles., • At least four (4) years of experience designing and implementing end-to-end performance test strategies, including workload modeling, scripting, execution, and reporting., • At least four (4) years of experience executing load, stress, endurance, and spike testing, including validation against defined performance SLAs (response time, throughput, error rate)., • At least four (4) years of experience translating non-functional requirements into measurable performance test scenarios, including volumetric models and workload distribution., • At least four (4) years of hands-on experience using performance testing tools like LoadRunner, JMeter or equivalent and performance monitoring tools like Elastic, Dynatrace, or equivalent., • At least four (4) years of experience testing APIs (REST/SOAP), validating latency, throughput, and error handling., • At least four (4) years of experience using test management and defect tracking tools like Micro Focus ALM, Azure DevOps, Jira., • At least four (4) years of experience using SQL or similar technologies for test data preparation and validation., • At least four (4) years of experience conducting bottleneck analysis and providing documented tuning recommendations based on performance results., • A Bachelor's degree in a Business Administration, Information Technology (IT) or Engineering Field. Additional qualifying experience may be substituted for the required education on a year for year basis., • Possesses a Master's degree in a Business Administration, IT or Engineering field., • At least ten (10) years of cumulative experience performing performance testing or performance engineering for large scale enterprise systems as defined above., • At least seven (7) years of cumulative experience leading enterprise-scale performance programs, including demonstrated improvements in SLA compliance or throughput optimization., • At least five (5) years of experience integrating performance testing into CI/CD pipelines like Azure DevOps, Jenkins with automated pass/fail gates., • At least three (3) years of experience performance testing cloud-based or SaaS systems, including autoscaling and distributed load strategies., • One (1) year of experience supporting large scale enterprise benefit systems (e.g., Unemployment Insurance or Disability Insurance) meeting defined large-scale enterprise system criteria. Required Skills/certs: • Possesses one or more of the below certifications: --> ISTQB Certified Tester Performance Testing (CT-PT), --> Open Text Load Runner Professional Developer Certification Exam, --> AWS Certified Solutions Architect – Associate, --> AWS Certified Solutions Architect / Performance Specialty. Preferred Education: • Possesses a Master's degree in a Business Administration, IT or Engineering field. This is C2C Contract Role Hybrid Model Please review the qualifications carefully. If you meet the above requirements, kindly send your resume to recruiter@sled-its.com

Location: Onsite – West Sacramento, CA Work Schedule: Onsite 5 days per week, no remote or hybrid option Employment Type: W2 only Candidate Preference: Green Card holders or U.S. Citizens preferred Submission Restriction: No layers, no third-party pass-through arrangements entertained Position Overview We are seeking a highly experienced Senior AI/ML Technical Project Manager to lead complex Technology projects involving artificial intelligence, machine learning, data analytics, cloud platforms, and enterprise IT delivery. The ideal candidate will have a strong background managing large-scale projects with budgets exceeding $1 million, leading cross-functional teams, and delivering projects using both Agile and Waterfall methodologies. This role requires a hands-on project leader who can manage multiple concurrent initiatives, coordinate with technical and business stakeholders, oversee project documentation, track risks and dependencies, and ensure delivery alignment with scope, schedule, budget, security, governance, and compliance expectations. Key Responsibilities The Senior AI/ML Project Manager will be responsible for: Project Management and Delivery · Manage complex IT, AI/ML, data analytics, and cloud-based projects with budgets exceeding $1 million. · Develop and maintain project plans, schedules, work breakdown structures, risk registers, status reports, and executive-level dashboards. · Use project management and collaboration tools such as MS Project, Jira, Confluence, or similar platforms. · Lead project delivery using Agile, Waterfall, or hybrid methodologies, depending on project needs. · Manage project scope, timelines, milestones, budgets, deliverables, risks, issues, and dependencies. · Coordinate multiple concurrent projects while ensuring timely completion and stakeholder alignment. · Facilitate sprint planning, backlog grooming, daily standups, retrospectives, steering committee meetings, and project status reviews as applicable. · Track vendor, contractor, internal team, and stakeholder deliverables. AI/ML and Data Analytics Project Leadership · Manage projects involving Artificial Intelligence, Machine Learning, data analytics, data pipelines, and model lifecycle activities. · Coordinate with data scientists, machine learning engineers, data engineers, cloud architects, application teams, business analysts, and security teams. · Support project activities related to AI/ML model development, testing, deployment, monitoring, documentation, and lifecycle governance. · Ensure project planning accounts for data readiness, data quality, model validation, integration dependencies, and operational support needs. · Communicate AI/ML project risks, assumptions, constraints, and progress to both technical and non-technical stakeholders. Cross-Functional Team Leadership · Lead cross-functional teams across business, technical, security, compliance, architecture, cloud, data, and operations groups. · Manage stakeholder expectations and ensure clear communication across project teams. · Drive decision-making, issue resolution, escalation management, and dependency tracking. · Facilitate collaboration among internal teams, external vendors, implementation partners, and executive stakeholders. · Promote accountability, transparency, and delivery discipline across all assigned projects. Documentation and Governance · Review, create, and maintain technical and project documentation, including: o AI/ML project documentation, Cloud architecture diagrams, API manuals, Project charters, Project schedules, Requirements traceability documents, Risk and issue logs, Decision logs, Status reports, Implementation plans, Transition and operational readiness documentation, Ensure documentation is complete, accurate, version-controlled, and aligned with project governance standards. · Support compliance with data governance, security, privacy, and regulatory requirements. · Work with security and compliance stakeholders to ensure project activities align with applicable standards and controls. Cloud, Data, and Security Coordination · Manage projects involving cloud platforms such as Microsoft Azure, Amazon Web Services, or similar cloud environments. · Coordinate activities involving cloud-based AI services, analytics platforms, APIs, integrations, and data pipelines. · Support planning and oversight for data governance, security, access controls, compliance reviews, and operational readiness. · Partner with architecture, infrastructure, cybersecurity, and data governance teams to manage project risks and dependencies. Minimum Qualifications (Must meet all the below) Candidates must meet the following minimum qualifications: 1.) 10 or more years of project management experience managing complex technology projects with budgets over $1 million. 2.) Proficiency with project management and collaboration tools such as: o MS Project, Jira, Confluence, Similar enterprise project tracking tools 3.) Strong working knowledge of Agile, Waterfall, and hybrid project delivery methodologies. 4.) 2 or more years of experience managing AI/ML and data analytics projects. 5.) Strong understanding of: o Artificial Intelligence concepts, Machine Learning concepts, Data analytics project delivery, Data pipelines, AI/ML model lifecycle 6.) 5 or more years of experience leading cross-functional teams and managing multiple concurrent projects. 7.) 2 or more years of experience managing cloud-based projects involving platforms (AWS, Azure) 8.) Bachelor’s degree in: Computer Science, Information Technology, Data Science, Or a related field 9.) Must be able to work onsite five days per week in West Sacramento, CA. 10.) 3 or more years of experience working with data governance, security, and compliance standards. 11.) Any experience with Public Sector projects, State and County is preferred

Job DescriptionManufacturing TechnicianQualificationsEducation & Experience • High school diploma or GED required, • Associate’s or Bachelor’s degree in Life Sciences or a related field preferred, • Prior experience in sterile or aseptic pharmaceutical manufacturing, • Experience working in a cGMP‑regulated environment is highly desirableKnowledge, Skills & Abilities, • Basic understanding of aseptic technique, cleanroom behavior, and contamination control (training provided), • Ability to read, understand, and follow SOPs, batch records, and manufacturing instructions, • Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods, • Strong attention to detail with clear and accurate documentation skills, • Ability to work both independently and as part of a team, • Willingness to work flexible shifts and weekends based on production needsAbout the Job Position Title: Manufacturing Associate This is an excellent foot‑in‑the‑door opportunity for candidates looking to begin or grow a career in pharmaceutical manufacturing. The Manufacturing Associate plays a critical role in sterile drug product manufacturing and will gain valuable hands‑on experience working in a cGMP‑regulated cleanroom environment. With strong performance, this role offers exposure to advanced aseptic processes and clear opportunities for professional growth and advancement. The Manufacturing Associate is responsible for performing aseptic and cleanroom manufacturing operations in compliance with cGMP regulations, regulatory requirements, and internal standard operating procedures (SOPs). This role requires attention to detail, consistency in execution, and a strong commitment to product quality and patient safety. Key Responsibilities • Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection, • Set up, operate, and clean manufacturing equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions, • Adhere strictly to gowning procedures and environmental controls to maintain aseptic conditions, • Follow batch production records (BPRs), SOPs, and material handling protocols accurately, • Support media fills, process validations, and cleanroom qualification activities, • Perform room and equipment sanitization in accordance with established cleaning schedules, • Complete all required training on time and maintain qualifications for aseptic operations, • Accurately document all activities in compliance with cGMP and data integrity requirements, • Assist with investigations, deviations, CAPAs, and continuous improvement initiatives, • Collaborate effectively with Quality, Validation, Engineering, and Technical Services teams, • Follow all safety, health, and environmental policies and procedures Job Type & Location This is a Contract position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $26.00 - $28.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on May 26, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Job DescriptionJob Title: Metrology Technician I Job Description The Metrology Technician I plays a pivotal role in supporting the calibration, maintenance, and repair of production, laboratory, and testing instruments to ensure compliance with regulatory standards. This role, under the guidance of senior staff, involves assisting with routine calibration tasks, troubleshooting, and documentation of results. It offers an excellent opportunity for individuals seeking to develop foundational skills in metrology. Responsibilities • Assist in performing routine calibrations of production, laboratory, and testing instruments according to established schedules and regulatory requirements under supervision., • Help perform minor repairs on plant and laboratory equipment, escalating complex issues to senior technicians or external vendors as needed., • Assist in maintaining accurate records of calibration activities, ensuring compliance with cGMP guidelines and internal procedures., • Collaborate closely with senior metrology staff to troubleshoot instrumentation issues and support metrology activities across departments., • Provide assistance in the temperature mapping program, including data collection and basic analysis under the guidance of senior technicians., • Participate in ongoing training to develop skills in metrology practices, calibration procedures, and regulatory compliance., • Ensure all assigned tasks are completed with attention to accuracy, compliance, and in a timely manner., • Perform other duties as assigned by the Metrology Supervisor.Essential Skills, • Organized, detail-oriented, and self-motivated., • Ability to apply advanced mathematical concepts., • Proficient in reading, analyzing, and understanding scientific and technical journals, financial reports, and legal documents., • Strong decision-making, communication, planning, and critical thinking skills., • Excellent analytical ability and problem-solving skills., • Accuracy in task completion.Additional Skills & Qualifications, • Bachelor’s degree in engineering, science, computer engineering, or equivalent combination of education and experience.Work Environment The work environment involves computer keyboarding, monitor and mouse use, requiring forward reaching, grasping, finger, and wrist manipulations. Frequent standing, sitting, walking, talking, and hearing are required, with occasional reaching, climbing, balancing, stooping, kneeling, crouching, or crawling. Employees may need to lift/move up to 50 lbs occasionally and up to 25 lbs frequently. Specific vision abilities required include close vision and color vision. Eye protection must be worn. Job Type & Location This is a Permanent position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $70000.00 - $80000.00/yr. Job Title: Metrology Technician I Department: Validation Reports To: Metrology Supervisor Status: Full Time/Non-Exempt JOB SUMMARY: The Metrology Technician I supports the calibration, maintenance, and repair of production, laboratory, and testing instruments to ensure compliance with regulatory standards. Under the supervision of senior staff, this role assists with routine calibration tasks, troubleshooting, and documentation of results. This position is ideal for candidates looking to build foundational skills in metrology. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Calibration Assistance: Assist in performing routine calibrations of production, laboratory, and testing instruments according to established schedules and regulatory requirements under supervision. 2. Instrument Repair Support: Help perform minor repairs on plant and laboratory equipment, escalating complex issues to senior technicians or external vendors as needed. 3. Documentation: Assist in maintaining accurate records of calibration activities, ensuring compliance with cGMP guidelines and internal procedures. 4. Team Collaboration: Work closely with senior metrology staff to troubleshoot instrumentation issues and support metrology activities across departments. 5. Temperature Mapping Support: Provide assistance in the temperature mapping program, including data collection and basic analysis under the guidance of senior technicians. 6. Training and Development: Participate in ongoing training to develop skills in metrology practices, calibration procedures, and regulatory compliance. 7. Compliance and Accuracy: Ensure that all assigned tasks are completed with attention to accuracy, compliance, and in a timely manner. 8. Additional Responsibilities: Perform other duties as assigned by the Metrology Supervisor. EDUCATION AND/OR EXPERIENCE: A Bachelors’ degree in such fields as engineering, science, computer engineering, etc. Or equivalent combination of education and experience. KNOWLEDGE, SKILLS & ABILITIES: This position requires the individual be organized, detail-oriented, and self-motivated and to apply advanced mathematical concepts. Ability to read, analyze, and understand scientific and technical journals, financial reports and legal documents. Decision making, communication, planning and critical thinking skills are a must. Analytical ability / problem solving, critical thinking skills along with accuracy is required. PHYSICAL REQUIREMENTS/WORKING CONDITIONS: The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning near vision is necessary for computer monitor use. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl. Employees must occasionally lift and/or move up to 50 lbs.; frequently lift and/or move up to 25 lbs. Specific vision abilities required for this job include close vision and color vision. Eye protection must be worn. Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on May 29, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Job DescriptionJob Title: Metrology Manager Job Description The Metrology Manager provides overall leadership, compliance oversight, and performance management for the metrology function supporting GMP manufacturing, laboratory, and validation environments. This role ensures the effective execution of calibration, maintenance, and temperature mapping programs in alignment with regulatory requirements, internal procedures, and industry standards. The Metrology Manager offers technical leadership, strategic direction, and personnel management to maintain accurate instrumentation, robust data integrity, and continuous improvement of metrology systems. The position serves as the primary interface for cross-functional support, audits, and vendor management. Responsibilities • Own and manage the site-wide metrology program, ensuring full compliance with cGMP, internal procedures, and applicable regulatory standards., • Ensure all calibration, maintenance, and repair activities are executed according to approved procedures and within established timelines., • Maintain a constant state of inspection readiness and actively support internal and external audits related to metrology activities., • Plan, schedule, and oversee the execution of all calibration activities through the CMMS system (such as Blue Mountain)., • Monitor adherence to calibration schedules and proactively address risks that may affect on-time completion of work., • Ensure calibration methods, tolerances, and acceptance criteria are technically sound, scientifically justified, and compliant with regulatory expectations., • Provide advanced technical guidance on complex calibration issues, instrumentation failures, and out-of-tolerance investigations., • Oversee troubleshooting and repair activities for instrumentation, including coordination with original equipment manufacturers and external service providers., • Approve technical decisions that impact instrument reliability, measurement accuracy, and compliance., • Supervise, train, and mentor metrology staff, including assigning workloads and managing performance., • Establish competency requirements for metrology roles and ensure ongoing technical development and training of team members., • Promote a culture of quality, accountability, safety, and continuous improvement within the metrology function., • Review and approve calibration, maintenance, and temperature mapping documentation for accuracy, completeness, and compliance., • Ensure timely initiation, investigation, and closure of Non-Conformance Reports, deviations, and CAPAs related to metrology activities., • Ensure consistent application of data integrity principles (ALCOA+) across all metrology records and systems., • Oversee temperature mapping studies for controlled environments such as warehouses, stability chambers, and incubators., • Ensure temperature mapping protocols, data analysis, and reports meet regulatory and internal quality expectations., • Define and approve sensor placement strategies for continuous monitoring systems to ensure representative and reliable measurements., • Partner with Quality and Operations to support equipment qualification and calibration activities across the site., • Manage vendor relationships for calibration services, equipment repairs, and metrology-related procurement., • Review and approve vendor service reports, ensuring alignment with internal standards and regulatory requirements., • Oversee procurement, control, and storage of calibration standards, ensuring traceability to NIST or equivalent standards., • Develop, track, and report metrology performance metrics, including on-time calibration completion, out-of-tolerance rates, and NCR or deviation trends., • Identify process gaps within metrology workflows and implement improvements to enhance efficiency, compliance, and reliability., • Lead initiatives to improve metrology systems, procedures, and technologies, including optimization of tools and processes., • Support implementation of new instrumentation and automation tools, ensuring proper integration into existing metrology programs., • Drive standardization and best practices across the metrology function to ensure consistency and scalability., • Perform other metrology and validation-related duties as assigned by leadership.Essential Skills, • Bachelor’s degree in Engineering, Science, or a related technical field, or an equivalent combination of education and experience., • Minimum of 5+ years of metrology, calibration, or instrumentation experience in a regulated environment., • Strong knowledge of cGMP requirements and their application to calibration and metrology programs., • In-depth understanding of calibration principles and metrology standards, including USP , USP , NIST traceability, and relevant ISO standards., • Proficiency with computerized maintenance management systems (CMMS), such as Blue Mountain, for planning and tracking calibration activities., • Advanced troubleshooting and analytical skills related to instrumentation and measurement systems., • Demonstrated leadership experience, including the ability to supervise, develop, and motivate technical staff; prior supervisory or leadership experience strongly preferred., • Strong organizational and decision-making skills with the ability to manage multiple priorities in a regulated environment., • Ability to interpret technical data, procedures, and regulatory requirements and translate them into practical metrology practices., • Effective verbal and written communication skills to support cross-functional collaboration and participation in audits., • Strong understanding of data integrity principles and documentation practices, including adherence to ALCOA+ guidelines.Additional Skills & Qualifications, • Experience leading or significantly contributing to site-wide metrology or calibration programs in GMP environments., • Background in supporting validation, equipment qualification, and temperature mapping activities., • Experience working with external calibration vendors and OEMs, including reviewing and approving service reports., • Familiarity with continuous environmental monitoring systems and sensor placement strategies., • Proven ability to develop and track performance metrics and use data to drive continuous improvement., • Experience implementing process improvements, standardization initiatives, or new technologies within metrology or calibration functions.Work Environment This is a full-time, exempt position within a validation-focused environment that supports GMP manufacturing and laboratory operations. The role involves frequent standing and walking throughout production and laboratory areas, with occasional climbing, stooping, kneeling, or crouching to access equipment and instrumentation. The position requires the ability to lift up to 50 pounds occasionally and 25 pounds frequently when handling equipment or calibration standards. Daily work includes extensive use of computers and instrumentation equipment, as well as interaction with CMMS tools and monitoring systems. The role operates in GMP-controlled areas where the use of personal protective equipment, including eye protection, is required, and adherence to gowning requirements and site safety procedures is mandatory. The environment emphasizes quality, compliance, and continuous improvement, with regular collaboration across Quality, Operations, and Validation teams and active participation in internal and external audits. Job Type & Location This is a Permanent position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $100000.00 - $120000.00/yr. Health dental vision 401k Nivagen Pharmacetuicals Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on Jun 1, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Pacific Sacramento Surgery Center, LLC (PSSC), a subsidiary of University of the Pacific, is launching a new Ambulatory Surgery Center (ASC) in Sacramento, California and is hiring our inaugural Surgical Technologist. This is a unique opportunity to help open a newly developed surgery center that will expand access to high-quality care for the community. Team members will play an important role in supporting the education and training of future healthcare professionals while delivering exceptional patient care. If you are energized by growth, innovation, and meaningful impact, we invite you to apply and be part of something new. Join Pacific Sacramento Surgery Center! This position is essential to the successful launch of a new surgery center. The Surgical Technologist will play a hands-on role in Operating Room (OR) setup, equipment opening and assembly, instrument organization, workflow development, and operational readiness. Responsibilities include assisting with room layout, equipment placement, vendor coordination, and preparing the OR for regulatory inspection and first-day operations. Once the Ambulatory Surgery Center (ASC) becomes operational, the role may transition into the standard Surgical Technologist scrub position. Essential Functions: PRE-OPENING (PHASE 1)Operating Room Setup & Readiness Unbox, assemble, and organize new surgical equipment, instruments, and supplies. Assist with OR layout, workflow design, and equipment placement. Perform and document equipment functionality checks. Participate in readiness walkthroughs, mock procedures, and equipment validation. Help establish daily OR setup, turnover, and closing routines. Instrument & Equipment Management Inventory, label, and catalog all instruments, devices, and supplies. Assist with assembling and organizing surgical instrument trays. Coordinate vendor in-servicing and training for staff. Establish sterilization, decontamination, and reprocessing workflows. Organize supply and storage areas to support efficient OR operations. Policy, Systems & Workflow Development Assist in developing and refining OR policies and procedures. Assist in sterile processing Standard Operating Procedures (SOP)s, emergency protocols, and infection control workflows. Support creation and maintenance of surgeon preference cards. Help define supply par levels, case cart processes, and documentation systems. Regulatory & Accreditation Preparation Assist in preparing for state inspection, Centers for Medicare & Medicaid Services (CMS) certification, and accreditation. Ensure compliance with labeling, documentation, room setup, and infection control standards. Support creation of pre-opening inspection and compliance checklists. Team Coordination & Training Work closely with OR leadership, anesthesia, surgeons, and admin staff. Assist with onboarding and training new clinical staff. Participate in soft-opening workflows, simulation days, and first-case readiness. POST-OPENING RESPONSIBILITIES (PHASE 2) Prepare the operating room and maintain the sterile field. Anticipate surgeon needs before and during surgery. Perform accurate sponge, needle, and instrument counts with circulating nurse. Clean, sterilize, and reassemble instrument trays. Restock rooms and maintain OR readiness at the end of each day. Comply with all safety, infection control, and facility policies. Perform all other duties as assigned. Minimum Qualifications: Education/Licenses: High school graduate. Current Basic Life Support (BLS) certification. Current Advanced Cardiovascular Life Support (ACLS) certification. Current Pediatric Advanced Life Support (PALS) certification. Experience: One (1) year of experience in perioperative, Post-Anesthesia Care Unit (PACU), OR, procedural, ambulatory, or related surgical setting required. Knowledge of: State, federal and accrediting body regulations. Standards related to ambulatory surgery center. Surgical procedures and practices. Perioperative nursing practice. Preferred Qualifications: Ambulatory Surgery Center (ASC) experience preferred, but not required for strong candidates with relevant surgical or procedural experience in dental, oral and maxillofacial surgery, head and neck surgery, ENT/Otolaryngology, facial and cosmetic surgery Certified Surgical Technologist (CST) certification. Maintains confidentiality of patient and organizational information. Demonstrates professionalism, leadership, and accountability. Participates in education and professional development. Supports proper chain of command and communication. Ability to: Demonstrate strong leadership, interpersonal communication, and effective delegation to support and manage clinical teams. Build and maintain positive working relationships with providers, physicians, dentists, staff, students, residents, hospital partners, and the wider healthcare community. Communicate clearly and professionally in verbal, written, and public-speaking contexts, ensuring patient-centered communication and service. Exhibit excellent organization, attention to detail, and multitasking skills, including the ability to remain focused amid frequent interruptions. Work independently, prioritize responsibilities, and meet established deadlines. Remain calm under pressure and manage inherently stressful situations with tact and professionalism. Make sound, reasonable decisions and respond promptly to clinical concerns. Foster a positive, collaborative, team-oriented environment. Display accountability, professionalism, openness, adaptability, creativity, and innovation. Utilize computers and electronic systems proficiently. Physical Requirements: The physical demands described here are representative but not definitive of those that must be met by an employee to successfully perform the essential functions of this job. Physically able to stand, sit, walk, climb, balance, stoop, kneel, crouch or crawl and maintain body positions for long periods of time. Hand-eye coordination and manual dexterity. Use of office equipment, phones, fax, email. Ability to use hands to finger, handle or feel objects or instruments. Ability to hear, see and speak. Ability to lift, transfer, move equipment and supplies up to fifty (50) pounds. Must be able to lift, turn, reposition, and transfer patients safely, with or without assistive devices. Requires working under variable conditions and/or working irregular hours. Direct contact with blood or other body fluids to which universal precautions apply. Personal protective equipment is made available and must be worn. Full Job Description/Apply here: _

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Engineer, MSAT works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. Physical Demands • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.Essential Duties & Key Responsibilities:, • Performs ongoing monitoring of existing commercial products and processes, • Generate metrics and reports for process monitoring and continuous process verification, • Support process improvements and changes including electronic batch record creation and modifications, • Performs Out of Trend Investigations based on trends from process monitoring, • Provides troubleshooting support for manufacturing events, equipment performance and material issues, • Performs root cause analysis to isolate cause of events and determine appropriate corrective actions, • Authors and owns change controls, technical protocols, reports and activities to support process improvements, • Writes and ensures proper execution of validation protocols and testing in line with required life cycle management activities, • Leads design, project management and execution of MSAT projects, introduction of new materials, and equipment at multiple GMP facilities, • Assess potential impact of supplier changes, material changes, Drug product labels, Drug Product packaging and cold chain transport changes and excursionsMinimum Qualifications:, • B.S. in Engineering or similar fields, • 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries, • Prior experience in regulated, GMP manufacturing operations, • Experience with data analysis and trending using JMP or other statistical software, • Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition Preferred Qualifications:, • Experience in biotechnology and cell therapy manufacturing preferred, • Experience with commercial packaging, labeling, and cold chain strongly preferred, • Excellent communication and problem solving skills, with a desire to improve upon established processes The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Job Description Ideal for recent undergraduate or graduate-level candidates with Salesforce back-end development experience. Position Summary The Salesforce Development & Data Systems Associate provides technical support for the design, maintenance, and enhancement of Umoja’s Salesforce infrastructure. This role is focused on Salesforce back-end development, data architecture, and database management, supporting program operations and reporting needs across the organization. This position is ideal for a Salesforce-certified professional who wants real-world experience building and maintaining production of Salesforce systems in a mission-driven environment. The Associate will work closely with the Research & Evaluation team and program staff to ensure data systems are accurate, scalable, and aligned with organizational needs. Key Responsibilities: Salesforce & Systems Development (75%) • Support the development and maintenance of Salesforce back-end architecture, including objects, fields, relationships, validation rules, and automation (Flows, Process Builder, or Apex as appropriate)., • Assist in managing Salesforce data models, user permissions, profiles, and roles., • Build and maintain custom reports, dashboards, and data views to support internal reporting needs., • Support Salesforce integrations, imports, exports, and data syncing processes., • Perform data cleaning, deduplication, and integrity checks within Salesforce., • Document system configurations, workflows, and data standards., • Collaborate with stakeholders to translate operational needs into technical Salesforce solutions. Data & Technical Support (25%) • Respond to internal Salesforce system requests, troubleshooting issues, and resolving data errors., • Support database management tasks using Excel, Google Sheets, or other data tools., • Assist with file uploads, structured data submissions, and quality assurance checks., • Provide technical support for related systems such as campus portals or data submission platforms. Work Expectations • 20–25 hours per week., • Approximately 50% in-office, with some flexibility., • Reports directly to the Senior Manager of Research & Evaluation. What This Role Offers • Hands-on experience building and managing real-world Salesforce systems., • Opportunity to deepen Salesforce development and data architecture skills., • Exposure to statewide higher-education and equity-focused initiatives., • A supportive environment for early-career technical professionals to grow., • Meaningful work that directly supports student success and institutional change. Requirements • Bachelor’s degree required; graduate-level students or master’s degree holders welcome., • Salesforce Administrator and/or Platform Developer I certification strongly preferred (required for hire or within first 3–6 months)., • Hands-on experience with Salesforce back-end configuration and development (academic, internship, or professional experience acceptable)., • Knowledge of database concepts (relational databases, data normalization, data integrity)., • Experience with data tools such as Excel or Google Sheets; familiarity with SQL or other database tools is a plus., • Strong attention to detail and ability to manage technical tasks independently., • Clear communication skills and ability to work with non-technical stakeholders., • Interest in education equity, data-informed decision-making, and student-centered systems. Benefits Hourly rate based on experience: $25–$30/hour. This is a 1099 Contractor position, no benefits offered.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Compounding Pharmacist (Full Time) The Compounding Pharmacist at Nivagen will be responsible for leading the 503B outsourcing facility, ensuring adherence to compounding standards and regulatory compliance. This role is pivotal in meeting manufacturing and company goals by overseeing the successful operations of a fully compliant department. Key responsibilities include maintaining facility and equipment standards, ensuring safety, upholding product quality, optimizing manufacturing efficiency, and managing quality systems in line with regulatory requirements. The Compounding Pharmacist will report directly to the CEO and/or the Production Manager. Responsibilities: • Work with Production Lead to achieve daily compounding output goals, • Design weekly production schedule with Production Lead, • Assign technician roles for the week (i.e. Mixer, Filler, Assistant, etc.), • Direct techs to a particular task to maintain production flow, • Complete Batch records, • Supervise compounding activities, • Perform Mixer, Filler, Assistant, or any technician duties as needed, • Check customer orders for accuracy, • Clinical customer service (Drug info, IV compatibility, osmolarity calculations etc.), • Controlled substance records management, • QA reports/investigations as assigned: MOCA, CAPA, MRDD, Complaints, • Maintain team's cGMP compliance at MSRX, • Participate in regulatory audits, • Draft SOPS revisions, process validation, draft a master compounding record, Process Validation etc, • Other duties as assigned by management or CEO and production manager Qualifications: Education/Experience: • Doctor of Pharmacy (Pharm.D.) degree from an accredited institution, • A minimum of two to three years of experience in a compounding pharmacy or a 503B outsourcing facility, or equivalent experience in related fields, is required Knowledge, Skills, and Abilities: • Understanding and experience in USP 797 guidelines and manual aseptic manipulations, • Strong leadership skills with the ability to manage and mentor a team, • Excellent communication and organizational skills, • Experience with regulatory audits and inspections is a plus., • Capable of maintaining confidentiality and handling sensitive information discreetly Requirements: • California Pharmacist License in good standing, • Knowledge and experience in cGMP and FDA 21 CFR parts 210 and 211, • Experience participating in a Manufacturing Unit in an FDA registered facility that includes cGMP compliance and sterile product preparation of pharmaceuticals OR experience as a pharmacist in a pharmacy that prepares sterile parenteral compounds, • Work in controlled environments and wear personal protective equipment as necessary, • Board certified Sterile Compounding pharmacist certification preferred., • Knowledge within the areas of quality control and process validation, • Familiarity and understanding of manufacturing methods related to quality control and quality assurance, • Experience participating in a supply chain management in an FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals, • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $180,000 - $180,000 per year, • Bonus Target eligibility determined by the President, • Performance-Based Incentive, • Benefits: Medical, Dental, and Vision coverage, • Paid time off plan, • 401 (k) savings plan Conditions of Employment: • This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, a gown, and other items as required, • This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR), • Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve-hour shift. Must be able to lift up to 50lbs, • Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals LLC, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Manufacturing Associate The Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen. The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures. Responsibilities: • Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection., • Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions., • Comply with all gowning requirements and environmental control procedures to maintain sterile conditions., • Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols., • Support execution of media fills, process validations, and cleanroom qualification activities., • Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies., • Complete all training in a timely manner and maintain qualification for aseptic operations., • Accurately record all activities in cGMP documentation, ensuring data integrity., • Assist with investigations, deviations, CAPAs, and continuous improvement initiatives., • Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs., • Follow safety, health, and environmental policies and procedures. Qualifications: Education/Experience: • High School diploma or GED required; Associate's or Bachelor's degree in Life Sciences or related field preferred., • Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred., • Experience in cGMP-regulated environments is highly desirable. Knowledge, Skills, and Abilities: • Strong understanding of aseptic technique, cleanroom behavior, and contamination control., • Ability to read and follow SOPs, batch records, and manufacturing instructions precisely., • Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods., • Detail-oriented with strong documentation and communication skills., • Ability to work independently and as part of a collaborative team., • Willingness to work flexible shifts and weekends as required by the production schedule. Requirements: • Valid driver's license and acceptable driving record., • Legally authorized to be employed in the United States., • This role is an on-site role and requires daily commuting to and from the facility., • This role requires work in a controlled cleanroom environment with strict gowning and hygiene protocols., • Must be able to stand for extended periods, lift up to 50 pounds, and perform repetitive tasks. Benefits: • Fulltime Employment, • $28 - $32 per hour, • Annual Bonus eligibility, • Medical, Dental, and Vision coverage, • PTO plan, • 401K plan Additional Information: Nivagen Pharmaceuticals affords equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals LLC, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Master Scheduler & Planner This position reports to the Vice President/ GM Manufacturing The Master Scheduler & Planner is responsible to plan and prepare production schedules for manufacturing and packaging of pharmaceutical products based on product sales information and product development and validation projects. This individual partners with Procurement to source, negotiate, and purchase direct and indirect materials within quality specifications and pricing guidelines. NOTE: Direct materials being anything that is used in production at internal and external facilities. Indirect materials being anything required for MRO, lab supplies and services, engineering, warehouse, and office supplies. Responsibilities: • This position is considered full-time (40 hours a week on average, sometimes more) position. Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions., • Develop production schedules for manufacturing in support of the overall business plan and to maximize plant efficiency. Maintain Excel spreadsheets and ERP entries in support of the production schedule., • Responsible for the assignment of target start and/or completion dates for manufacturing and packaging operations., • Conducts daily scheduling meeting with Operations and Supporting Departments., • Coordinate raw materials and component availability, laboratory release, quality and distribution activities to meet product delivery and inventory needs., • Troubleshoot problems associated with the manufacturing and packaging of the products and how they impact the schedule., • Work with Purchasing to determine order quantities and frequency to meet forecasted sales levels., • Schedule and coordinate the manufacturing and packaging activities for new products and product changes., • Schedule and monitor the production schedule to ensure customer needs and maintain minimum inventory level., • Produce status reports that monitor product inventory levels and packaging performance., • Assist in the development of guidelines and procedures to ensure quality, cost containment and customer service., • Supplier Relationship Management:, • Working with Supply Chain planners, identify key suppliers and implement supplier management program to improve quality, delivery timeliness, cost, and performance., • Develop KPIs and scorecards for quarterly reviews of supplier performance., • Identify opportunities for cost reduction and improvements., • Perform any other related duties as required or assigned. Qualifications: Education/Experience: Four-year college degree, or equivalent experience resulting in broad knowledge of a field related to the job, such as accounting, marketing, business administration, agriculture etc, plus 4 years related experience and/or training Or equivalent combination of education and experience. • Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred., • Experience in cGMP-regulated environments is highly desirable. Knowledge, Skills, and Abilities: • Ability to write reports, business correspondence, and policy/procedure manuals, • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public., • Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume, • Ability to apply concepts such as fractions, ratios, and proportions to practical situations., • Ability to define problems, collect data, establish facts, and draw valid conclusions, • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables, • Willingness to work flexible shifts and weekends as required by the production schedule. Physical Requirements: • Legally authorized to be employed in the United States., • This role is an on-site role and requires daily commuting to and from the facility., • The following physical activities described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and expectations., • While performing the functions of this job, the employee is continuously required to sit, use hands to finger, handle, or feel, talk or hear; occasionally required to walk. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Benefits: • Fulltime Employment, • $85,000 - $120,000 annual salary, • Annual Bonus eligibility, • Medical, Dental, and Vision coverage, • PTO plan Additional Information: Nivagen Pharmaceuticals an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Nivagen Pharmaceuticals will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. Nivagen Pharmaceuticals uses E-Verify.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: In Process QA Specialist (Full Time) At Nivagen as an In Process QA Specialist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Responsibilities: In this role, you will: · Perform routine on-the-floor QA oversight within manufacturing areas, providing real-time quality support and ensuring compliance with approved procedures and GMP requirements. · Conduct line clearances, in-process checks, and verification activities during manufacturing and packaging operations. · Review and approve GMP documentation including batch production records, logbooks, sampling records, and associated manufacturing documentation. · Support deviation investigations by gathering information, participating in root cause analysis, and assisting with CAPA development and effectiveness checks. · Support the authoring, review, and approval of QA Manufacturing procedures, controlled documents, and Master Batch Records to ensure compliance with cGMP, regulatory requirements, and internal quality standards. · Participate in GMP area walkthroughs and support inspection readiness activities. · Support internal audits, regulatory inspections, and customer audits by preparing documentation and providing operational support. · Collaborate cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams to resolve quality issues and drive continuous improvement. · Assist with product disposition activities and quality review processes under supervision. · Promote a culture of quality, compliance, and operational excellence within the organization. Qualifications: Education/Experience: · Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field OR equivalent combination of education and sterile GMP manufacturing experience. · 0–3 years of experience in sterile pharmaceutical, biotech, or other regulated manufacturing environments. · Working knowledge of current Good Manufacturing Practices (cGMP) and applicable FDA regulations (21 CFR). · Strong organizational skills and attention to detail. · Effective written and verbal communication skills. · Ability to work independently while collaborating within cross-functional teams. · Basic knowledge of deviation management, CAPA, and change control processes preferred. · Familiarity with electronic systems such as ComplianceWire, TrackWise, SAP, LIMS, or similar eQMS platforms preferred. · Proficiency in Microsoft Office applications. Knowledge, Skills, and Abilities: • Strong analytical and problem-solving skills with experience in root cause analysis and CAPA implementation, • High level of attention to detail, particularly in identifying quality deviations and documenting production processes, • Proficiency in using quality testing equipment and familiarity with statistical process control (SPC) methods, • Strong understanding of GMP, FDA regulations, and other relevant pharmaceutical industry standards, • Excellent communication skills, both verbal and written, for effective collaboration and documentation, • Ability to work effectively as part of a cross-functional team, including production, quality control, and regulatory affairs Job Requirements: Physical / Mental Requirements · Ability to apply sound judgment and make decisions aligned with company procedures and regulatory standards. · Strong analytical and problem-solving skills. · Ability to gown and work within controlled cleanroom environments. · Must be able to wear appropriate PPE (safety shoes, glasses, gloves, etc.). · Ability to stand for extended periods during manufacturing oversight activities. Work Environment / Schedule · Primarily day shift, Monday–Friday. · May require flexibility to support manufacturing operations, including occasional off-shift or weekend coverage. · Work Location Assignment: On-site / Manufacturing Facility ·This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment ·Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $70,000 - $80,000 per Year, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Job DescriptionHR Benefits Specialist II Location: Sacramento, CA Schedule: Hybrid, Monday-Friday Position Summary This role is responsible for benefits eligibility, enrollment, life event processing, claims support, and vendor coordination, while ensuring accurate system data, compliance, and high-quality employee service. Responsibilities • Administer employee health and welfare benefits, including eligibility determination, enrollments, and life event changes, • Support benefits claims review and appeals by gathering, reviewing, and documenting required information, • Maintain accurate case files and HRIS data prior to transmission to third-party administrators, • Reconcile premium billing, vendor reports, and benefits invoices, • Audit benefits data and support compliance, reporting, and validation activities, • Respond to escalated employee inquiries and coordinate issue resolution with vendors and internal teams, • Support open enrollment activities, wellness programs, education assistance reimbursements, and year-end processes, • Track cases, documentation, and issue resolution in a high-volume environment, • Participate in process improvements, system testing, and user acceptance testing (UAT) as neededQualifications, • High School Diploma or equivalent experience, • Minimum 1 year of experience in HR operations, benefits administration, or a related HR support role, • Experience with benefits eligibility, enrollment, claims, or appeals processing, • Experience working with HRIS or benefits administration systems, • Ability to interpret benefits policies, regulations, and compliance requirements, • Experience reconciling benefits billing, premiums, or vendor reports, • Experience supporting third-party administrators or benefits vendors, • Strong data entry, reporting, and documentation skills, • Ability to perform basic calculations (percentages, deductions, premiums), • Experience managing multiple cases and priorities in a deadline-driven environment, • Experience in healthcare or large enterprise HR environments, • Experience supporting open enrollment and qualifying life event changes, • Exposure to audit processes, data validation, or compliance reviews, • Participation in UAT or HR systems testing, Microsoft Excel or reporting tools, • Experience working in shared services or centralized HR operationsBenefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. Pay Details: $35.00 to $40.00 per hour Search managed by: Savannah Mckillip Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance OrdinanceMassachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Job Description Build your career at DeSilva Gates Construction, where you’ll be part of a team delivering major infrastructure projects across Northern California. We are seeking a strategic Estimator to join our Sacramento team- a detail-oriented professional who thrives on precision, collaboration and delivering impactful results. The ideal candidate brings strong analytical expertise and relationship-building skills, developing accurate and competitive cost estimates while partnering closely with internal teams and external stakeholders. This role offers the opportunity to influence project outcomes, support bid strategies and contribute to the successful delivery of a diverse portfolio of infrastructure projects. Responsibilities Estimating & Cost Analysis • Review specifications, drawings, and project site conditions to develop accurate estimates., • Analyze and build estimate data related to labor, materials, equipment, location and other cost factors., • Apply mathematical calculations to ensure accuracy of estimated costs., • Utilize historical cost data as a benchmarking tool., • Review quantity take-offs to verify accuracy of estimate inputs. Bid Strategy & Competitive Analysis • Analyze alternative construction methods and approaches to improve bid competitiveness., • Evaluate projects risks and develop strategies to mitigate potential construction challenges. Vendor & Subcontract Coordination • Communicate with subcontractors and suppliers to obtain pricing and scope details. Internal Collaboration & Reporting • Present estimate/proposal to management for review and validation., • Communicate bid information and project scope to field operations during pre-construction meetings. Requirements Qualifications • Bachelor’s degree in civil engineering, construction management, business administration, or equivalent related work experience., • 5 years of estimating experience preferred- public or private., • Prior experieince as a Project Manager/Engineer and/or take-off, is a plus., • Ability to manage and produce multiple estimates simultaneously., • Proficiency in Microsoft Office products (Outlook, Word, Excel, PowerPoint.) and Primavera Scheduling software., • Strong working knowledge of estimating software such as HCSS HeavyBid., • Working knowledge of construction methods and principles., • Strong verbal and written communication skills. Able to communicate with internal and external personnel of all levels. Who Are We Looking For? • Strong analytical skills with the ability to interpret complex information and make sound decisions., • High attention to detail and accuracy, especially in a deadline-driven environment., • Ability to cultivate and maintain strong relationships through effective collaboration., • Proactive and forward-thinking, with the ability to anticipate challenges and plan accordingly., • Collaborative, adaptable and responsive with a timely mindset. Additional Requirements • Required to pass pre-employment drug and alcohol screening. Benefits Total compensation package includes the following: • Pay (base salary) from $170,000/year (depending on qualifications), • Profit sharing- cash and deferred, • Vehicle allowance & gas card, • Comprehensive coverage- health, dental, vision (Competitive premiums with participation in yearly wellness program), • Insurance- life and disability, • Paid time off and Paid holidays, • 401k plan, • Financial planning assistance, • Career growth and development DeSilva Gates Construction is a place to build a strong, growth‑focused career supported by mentorship from industry leaders. We deliver heavy civil construction projects with integrity, professionalism, and a commitment to excellence—while helping our employees advance and succeed. Founded in 1932, we are an award‑winning contractor specializing in grading, paving, and construction management. Our culture is rooted in safety, respect, teamwork, and clear communication, with a family‑oriented, client‑focused approach grounded in honesty and accountability. We’re looking for self‑motivated, ethical professionals who take ownership, build strong relationships, and thrive both independently and in teams. With a wide range of public and private projects, you’ll have opportunities to grow and take on meaningful challenges. DeSilva Gates Construction is committed to a diverse and inclusive workplace and is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. For more information about DeSilva Gates Construction please visit our web site at www.desilvagates.com.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals LLC, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet all regulatory requirements, industry standards, and company specifications. The role involves independently working and supporting the validation lifecycle from installation through qualification and routine re-validation activities, ensuring that the company's sterile manufacturing processes are in compliance with cGMP (current Good Manufacturing Practices) and other regulatory guidelines such as FDA, EMA, and ISO standards. Responsibilities: • Qualification of Equipment and Systems:, • Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems., • Qualification of equipment in sterile manufacturing facility (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization)., • Ensure compliance with regulatory requirements for equipment qualification and validation., • Knowledge of validation equipment like Kaye validator, temperature and RH data loggers etc., • Validation Documentation and Protocols:, • Prepare and review validation reports to ensure they meet regulatory and company requirements., • Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored., • Process Validation and Cleaning Validation:, • Conduct and manage process validation studies to confirm the sterility and quality of pharmaceutical products., • Work with cross-functional teams (e.g., production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability., • Support the development and implementation of new processes, ensuring that they are validated per regulatory requirements., • Knowledge of cleaning validation will be an added advantage, • Perform any additional tasks as assigned by the Validations Lead Qualifications: Education/Experience: • Bachelor's degree or Diploma in Pharmaceuticals, or a related field., • Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization)., • Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements., • Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation., • Familiarity with the documentation requirements for validation, including protocol development, execution, and report writing Knowledge, Skills, and Abilities: • Excellent technical writing and documentation skills., • Strong attention to detail and ability to manage complex technical documentation., • Ability to work cross-functionally and manage multiple priorities., • Familiarity with data analysis tools and software used for validation testing and reporting (e.g., Excel, Validation Master Plans, LIMS systems)., • Aseptic processing or sterile manufacturing practices. Requirements: • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Willing to travel as needed basis to other manufacturing sites for vendor support Work Environment: • Cleanroom and sterile production areas with controlled environments., • Potential exposure to hazardous materials and chemicals used in pharmaceutical manufacturing processes. Benefits: • $90,000 to $105,000, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job Description Job Title: Manufacturing Equipment Engineer Location: Burlingame, CA Department: Manufacturing Engineering Reports to: Manufacturing Equipment Engineering Manager Position Type: Full Time About the Company Peak Energy is the first American venture to advance globally proven Sodium-Ion battery systems as the storage standard for the new era of renewable energy on a resilient grid. Sodium-Ion is cheap, readily available and safe, making it the leading contender in a rapidly evolving market. Our leadership team is powered by decades of expertise in scaling gigawatt-level innovation at world-class companies such as Tesla, Northvolt, SunPower, Fluence, and Enovix. We are backed by strategic investment and product partners such as TDK Ventures and Eclipse Ventures. About the Job: Peak Energy is seeking a highly motivated Manufacturing Equipment Engineer to lead the development, deployment, and optimization of manufacturing equipment across our current operations and future factory expansions. This role will play a critical part in building out production lines at our Sacramento facility, owning the end-to-end execution of equipment strategy—from early concepting and Design for Manufacturability (DFM) through vendor coordination, installation, commissioning, and validation. In this position, you will be responsible for designing and implementing manufacturing equipment and tooling to enable efficient, scalable production processes. You will drive the introduction of new machinery, automation systems, and production line enhancements, ensuring all equipment meets production requirements, safety standards, and operational efficiency goals. As the central point of ownership for equipment-related workstreams, you will partner closely with cross-functional teams including process, quality, design, and manufacturing to deliver fully operational, production-ready lines. This is a highly hands-on, cross-functional role that will directly impact Peak Energy's ability to scale ESS production toward 1 GWh capacity by 2027. Responsibilities: • Design and develop complete manufacturing lines for both in-house builds and supplier sourced equipment, bringing lines from concept through commissioning and ramp., • Define equipment concepts, technical specifications, and performance requirements for high volume manufacturing, • Lead the RFQ process, supplier selection, and technical reviews for new manufacturing equipment, • Coordinate factory readiness, utility requirements, installation, and commissioning activities, • Travel domestically and internationally, up to 20%, as required, • Support the transition of products and processes from low‑volume prototype builds to full‑scale manufacturing, • Collaborate with Process Engineering to refine, industrialize, and deploy scalable manufacturing processes, • Support line optimization efforts throughout ramp and production maturity Minimum Qualifications: • Strong understanding of mechanical design fundamentals, including materials, GD&T, drafting standards, and engineering calculations, • Proficiency in mechanical CAD and layout development (e.g., SolidWorks, NX, CATIA 3DEXPERIENCE, AutoCAD). AutoCAD & CATIA 3DEXPERIENCE preferred., • Experience designing and sourcing custom manufacturing equipment, tooling, and mechanical systems., • Experience supporting multiple equipment installations and product launches., • Working knowledge of manufacturing quality practices (e.g., PFMEA, control plans), • Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or related field (or equivalent practical experience), • Strong verbal, written, and presentation skills Preferred Qualifications: • 4+ years of experience in manufacturing equipment design, commissioning, or industrial automation (All experience levels encouraged to apply)., • Knowledge of machine safety standards and regulatory requirements, • Familiarity with automation architectures, sensors, actuators, and PLC‑based systems, • Experience working with integrators and capital equipment suppliers, • Background in high‑volume, highly regulated industries (automotive, energy storage, aerospace, medical devices), • Demonstrated ability to manage multiple projects in fast‑paced environments, • Experience applying Design for Manufacturability (DFM) principles Compensation and Benefits The salary range for this role is $125k- $185k, with actual pay varying based on work location, experience, and skills. Our competitive benefits package includes flexible time off, comprehensive medical, dental, and vision coverage, a strong 401(k) plan, and equity opportunities. Join us to thrive in a supportive environment while making a meaningful impact in the energy sector!

Job DescriptionAbout BuildingWorks BuildingWorks creates a memory for buildings. We handle 100% of construction closeout documentation, reducing timelines from the industry standard of 4-6 months to 30-60 days. Since 1999, we have completed 500+ projects for leading general contractors and building owners across 20+ states. Our DataSphere platform delivers organized, searchable documentation that facility teams actually use, not boxes of binders that sit in storage rooms. Location Disclaimer: While a specific location is listed for this role, we are open to candidates from other cities and locations. The listed location is required for posting purposes and does not limit our search to that area. The Role As a Project Closeout Consultant, you will manage all aspects of closeout documentation collection, organization, validation, and delivery for commercial construction projects. You are the person who makes sure nothing gets lost in the handoff from construction to operations. This role requires attention to detail, comfort working with construction documents, and the ability to coordinate with multiple subcontractors and project teams simultaneously. What You Will Do Document Collection and Management You will collect closeout documentation from general contractors and their subcontractors throughout construction. This includes equipment specifications, operation and maintenance manuals, warranties, as-built drawings, commissioning reports, test and balance reports, and training materials. You will track submission status, follow up on outstanding items, and ensure all required documents are received. Organization and Verification You will organize documentation in our DataSphere platform by system, room, manufacturer, and drawing number. You will verify that submitted documentation matches contract requirements and installed equipment. When you find a manual for the wrong model or a missing warranty, you will track it down and get it corrected. Quality Assurance and Audit You will audit documentation packages for completeness and accuracy before delivery. This means validating that the HVAC manual matches the installed equipment serial numbers, the electrical panel schedules reflect as-built conditions, and all required warranties are documented with proper start dates and coverage periods. Client Coordination You will work directly with project managers, project engineers, and subcontractors to collect documentation. You will provide status updates to general contractors and participate in closeout coordination meetings. You will train building owners and facility managers on DataSphere navigation and features upon project delivery. Project Management You will manage multiple projects simultaneously at different stages of completion. Some projects will be in early collection phases while others are in final delivery. You will track progress against milestone schedules and flag issues before they become problems. What You Bring Required Experience 2+ years working with construction documentation, project management, or facilities management Familiarity with construction closeout processes and typical documentation requirements Experience reading and interpreting construction drawings and specifications Proficiency with document management systems and cloud-based platforms Strong organizational skills with the ability to track hundreds of documents across multiple projects Preferred Experience Background as a project engineer, project coordinator, or assistant project manager with a general contractor Experience in facilities management or building operations Knowledge of MEP systems (mechanical, electrical, plumbing) and building equipment Familiarity with CSI specification divisions and submittal processes Experience with construction management software Skills and Attributes Detail-oriented with a low tolerance for incomplete or inaccurate information Comfortable communicating with subcontractors, project managers, and building owners Self-motivated and able to work independently on multiple concurrent projects Problem solver who finds missing documents rather than just noting they are missing Clear written communication for status reports, emails, and documentation notes What We Offer Competitive compensation based on experience Remote work flexibility with occasional project site visits Opportunity to work on diverse projects across commercial, healthcare, education, and industrial sectors Direct impact on project outcomes and client satisfaction Growth opportunities as BuildingWorks expands

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Microbiologist Laboratory Reviewer (Full Time) At Nivagen as a Microbiologist Laboratory Reviewer you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Position Summary The Microbiology Laboratory Reviewer plays a critical role in ensuring the accuracy and compliance of microbiological data within an injectable manufacturing facility. This position is responsible for reviewing laboratory test results, protocols and reports batch records, and related documentation to verify adherence to standard operating procedures (SOPs), current Good Manufacturing Practices (cGMP) regulations, GLP, and company quality standards. The reviewer works closely with laboratory microbiologist and quality assurance teams to resolve discrepancies, support investigations, and ensure the timely release of products. Key responsibilities include evaluating microbiological method validations, transfers, and investigations, as well as assessing environmental monitoring data, sterility test outcomes, and endotoxin results. The role also involves identifying trends, supporting continuous improvement initiatives, and providing guidance on best practices in documentation and data integrity. Strong attention to detail, effective communication skills, and a commitment to maintaining high standards of safety and compliance are essential for success in this position. Duties and Responsibilities Reviews and verifies laboratory test results, ensuring compliance with SOPs, cGMP, and company policies. Evaluates method validations, transfers, and microbiological investigations for accuracy and completeness. Assesses environmental monitoring data, sterility, and endotoxin testing outcomes for quality and consistency. Collaborates with laboratory analysts and quality assurance teams to resolve discrepancies and address out-of-specification results. Supports investigations related to laboratory deviations and participates in root cause analysis. Ensures timely review and release of batch records and product documentation. Identifies trends or recurring issues in laboratory data and recommends corrective actions. Supports the implementation of process improvements and best practices in microbiological testing and documentation. Provides training and guidance to laboratory staff on data integrity and compliance requirements. Maintains thorough records of all review activities and ensures proper documentation is in place. Calibration and maintenance coordination and record. Participates in internal and external audits as required, providing relevant documentation and expertise. Ensures all work is conducted in accordance with health, safety, and environmental regulations. Demonstrates strong organizational skills and manages workload to meet project timelines and regulatory deadlines. Maintains confidentiality and handles sensitive information with professionalism and integrity. Continuously updates knowledge of relevant regulations, industry trends, and technological advancements in microbiology. • Performs other duties as assigned. While performing the responsibilities of the job, the employee is required to talk and hear. Must be able to bend at the waist and knees as well as twist at the trunk. Must be able to lift up to 25 lbs. Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. Personal protective equipment and Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting Microbiological method development and method validation procedures like BET, Sterility, MLT, Bio Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation. Knowledge and Skills • Strong knowledge of microbiological testing techniques, reviewing, methods, and equipment. Key Competencies • Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions., • Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement., • Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives., • Resourcefulness: Secures and deploys resources effectively and efficiently., • Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems., • Ensures Accountability: Holds self and others accountable to meet commitments and objectives., • Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations., • Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences. Experience and Qualifications • Bachelor's degree in microbiology, Biology, or related field required; Master's degree preferred., • Minimum of 3 years of experience in a microbiology laboratory required., • Previous experience in a pharmaceutical or compounding environment preferred., • Experience with compendia testing: United States Pharmacopeia, and regulatory requirements (Food and Drug Administration and cGMP) preferred., • Experience with microbiological method development and method validation procedures like Sterility Testing, Endotoxin Testing, Disinfectant Efficacy Study, Water Testing, Method Validation, Environment Monitoring, Microbial Limit Testing, PET, and microbiological hold time validation, container closure integrity. Benefits: • Pay range $75,000-$85,000 per Year, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Job Description Job Title: Functional Systems Lead Location: Burlingame, CA Department: ESS Engineering Reports to: CTO Position Type: Full Time About the Company Peak Energy is the first American venture to advance globally proven Sodium-Ion battery systems as the storage standard for the new era of renewable energy on a resilient grid. Sodium-Ion is cheap, readily available and safe, making it the leading contender in a rapidly evolving market. Our leadership team is powered by decades of expertise in scaling gigawatt-level innovation at world-class companies such as Tesla, Northvolt, SunPower, Fluence, and Enovix. We are backed by strategic investment and product partners such as TDK Ventures and Eclipse Ventures. About the Job: Peak Energy is seeking a Functional Systems Lead to own system-level architecture, requirements, and integration across embedded software, electrical systems, and controls for our energy storage products. This role sits at the intersection of embedded systems, electrical engineering, and system modeling, ensuring our products are safe, reliable, and performant from cell to grid. You will lead the definition of functional requirements, system behavior, and safety architecture, while partnering closely with embedded, hardware, and modeling teams—and may directly oversee embedded software development for safety-critical functions. This is a highly cross-functional, hands-on leadership role ideal for someone who thrives in ambiguity and wants to shape both product and engineering direction. Responsibilities: • Own system-level architecture and functional definition for energy storage systems (BMS, controls, protections, EMS integration), • Define and manage system requirements, interfaces, and traceability from cell → module → pack → system → grid, • Lead functional safety architecture, including fault detection, diagnostics, and protection strategies, • Drive systems integration across embedded software, power electronics, thermal, and mechanical subsystems, • Partner with embedded teams to guide development of real-time, safety-critical firmware (controls, protections, communication), • Develop and validate system models (performance, thermal, electrical behavior, fault conditions) to inform design decisions, • Lead verification & validation strategy (DV/PV), including test definition, coverage, and requirements validation, • Support certification efforts (UL, IEC, IEEE), ensuring compliance at the system level, • Identify system risks and drive DFMEA, fault analysis, and mitigation strategies, • Build and mentor a high-performing systems/embedded team, setting clear ownership and technical direction Minimum Qualifications: • 10+ years of experience in systems engineering, embedded systems, or electrical engineering, with 3–5+ years in technical leadership, • Strong background in safety-critical systems (battery systems, automotive, aerospace, industrial, or similar), • Experience defining and managing system requirements, interfaces, and architecture, • Deep understanding of embedded systems and real-time controls, • Familiarity with electrical systems (power electronics, battery systems, sensing, protections), • Experience with system modeling and simulation (MATLAB/Simulink, Python, or similar), • Strong experience with DFMEA, fault handling, and system reliability engineering, • Experience driving cross-functional integration across hardware, software, and systems teams, • Excellent communication skills and ability to operate across multiple technical domains, • Bachelor's, Master's, or PhD in Electrical Engineering, Mechanical Engineering, Computer Engineering, or related field Preferred Qualifications: • Experience with battery management systems (BMS) or energy storage systems, • Background in functional safety standards (ISO 26262, IEC 61508, UL 9540, etc.), • Experience leading or mentoring embedded software teams, • Familiarity with grid-scale energy systems, EMS, or power systems integration, • Experience in startup or high-growth environments Compensation and Benefits The salary range for this role is $150k- $225k, with actual pay varying based on work location, experience, and skills. Our competitive benefits package includes flexible time off, comprehensive medical, dental, and vision coverage, a strong 401(k) plan, and equity opportunities. Join us to thrive in a supportive environment while making a meaningful impact in the energy sector!

Job DescriptionAre You Ready?CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard—through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles- At CAI, we are committed to living our values—both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future- We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity—always focused on how it will be done, not how it used to be done. Key Responsibilities1. Technical Responsibilities- Develop documentation for CQV activities- Write and execute protocols (field verification)- Develop summary reports at client sites2. Areas of Focus- Pharmaceutical facilities- Utilities- Equipment3. Project & Team Management- Plan and coordinate work- Direct small teams in document development and/or execution Qualifications and Experience- Bachelor’s degree in a science or engineering field (or equivalent experience)- 2–4 years’ experience in commissioning and qualification in a regulated industry- Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus- Preferred experience in:- Facilities and equipment startup- Walk-downs and troubleshooting- Utilities (WFI, RO, HVAC)- Upstream/downstream processing- Purification, recovery- Building automation- Pharmaceutical manufacturing processes Critical CompetenciesInfluence Strategy- Pursues initiatives aligned with organizational strategy- Identifies strategic, innovative solutions- Anticipates emerging customer/market needs Satisfy the Customer- Understands and anticipates customer needs- Delivers high-quality solutions and service- Proactively maintains satisfaction and loyalty Plan for Success- Aligns business strategies with actionable plans- Anticipates risks and builds contingency plans- Secures resources for goal achievement Pursue Execution- Prioritizes time and resources effectively- Holds self and others accountable- Acts to overcome obstacles and improve quality Tailor Communication- Communicates clearly and professionally- Adjusts style to fit the audience- Explains technical concepts effectively Build Partnerships- Builds networks across functions- Encourages collaboration and breaks down silos- Involves stakeholders in decisions Influence Others- Builds support with sound rationale- Gains buy-in from decision makers- Encourages innovative thinking Develop Self and Others- Enhances interpersonal relationships- Models integrity and company values- Seeks out growth and breakthrough opportunities#LI-MV1Average base salary range - not including benefits, and potential overtime and Cost of Living Adjustment. CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Microbiologist (Full Time) At Nivagen as a Microbiologist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Position Summary As a Microbiologist you will play a critical role in the success of our operations. This position is integral to our commitment to excellence, as it involves developing and validating microbiological test methods, maintaining detailed records, and preparing reports, protocols, and standard operating procedures (SOPs). Your expertise will directly contribute to Quality and affordable medication. Collaboration is key in this role. You will work closely with cross-functional teams to meet project objectives and timelines and identify opportunities for process improvements. Your proactive approach and innovative mindset will help us enhance efficiency and effectiveness within our microbiology laboratory and reinforce our dedication to quality and compliance. Additionally, in this influential role you will be a mentor, providing training and guidance to microbiology staff, fostering an environment of continuous learning and professional growth. Joining Nivagen as a Microbiologist means being part of a visionary team dedicated to expanding access to quality, affordable medication. If you are passionate about quality, service, and innovation, and are eager to make a difference in people's lives, we invite you to bring your expertise and enthusiasm to our dynamic team. Duties and Responsibilities • Conducts microbiological testing of primary packaging materials, raw materials, in process sample, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing., • Develops and validates microbiological test methods in accordance with compendial and regulatory requirements., • Maintains accurate and detailed records of all microbiological testing and analysis performed. Prepares and reviews reports, protocols, and SOPs related to microbiological activities., • Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Participate in internal and external audits as needed., • Microbiology-related projects, including method transfers, validations, and investigations., • Collaborates with cross-functional teams to achieve project objectives and timelines., • Provides training and mentorship to microbiology staff., • Shares knowledge and expertise to promote continuous learning and development within the microbiology team., • Identifies opportunities for process improvements and optimization within the microbiology laboratory., • Implements best practices and innovative solutions to enhance efficiency and effectiveness., • Performs a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials., • Performs other duties as assigned. While performing the responsibilities of the job, the employee is required to talk and hear. Must be able to bend at the waist and knees as well as twist at the trunk. Must be able to lift up to 25 lbs. Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. Personal protective equipment and Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting Microbiological method development and method validation procedures like BET, Sterility, MLT, Bio Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation. Knowledge and Skills • Strong knowledge of microbiological testing techniques, methods, and equipment. Key Competencies • Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions., • Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement., • Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives., • Resourcefulness: Secures and deploys resources effectively and efficiently., • Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems., • Ensures Accountability: Holds self and others accountable to meet commitments and objectives., • Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations., • Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences. Values People: Our people define who we are as a company. We believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth. By prioritizing the well-being and development of our employees, we create an environment where everyone can thrive and contribute their best. Quality: Quality stands at the core of our mission. It reflects our commitment to excellence in every medication we produce. We adhere to the highest standards of quality control and continuously strive to improve our processes to ensure that our products meet the needs of those we serve. Our dedication to quality is unwavering and is evident in every aspect of our work. Service: We are here to serve others. Every interaction with our patients, providers, employees, and other stakeholders comes from a place of service. We are committed to delivering exceptional service and ensuring that every experience with our company is positive and impactful. Our service-oriented approach helps us build strong, lasting relationships and fulfill our mission of improving healthcare outcomes. Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care. Innovation drives us to find better ways to serve our patients, improve our products, and streamline our operations. We are committed to staying ahead of industry trends and leveraging cutting-edge technology to enhance the value we provide. In summary, our core values—People, Quality, Service, and Innovation—are integral to everything we do. They guide our actions, shape our culture, and inspire us to achieve excellence in all our endeavors. By staying true to these values, we ensure that we fulfill our mission and make a positive impact on the lives of those we serve. Experience and Qualifications • Bachelor's degree in microbiology, Biology, or related field required; Master's degree preferred., • Minimum of 3 years of experience in a microbiology laboratory required., • Previous experience in a pharmaceutical or compounding environment preferred., • Experience with compendia testing: United States Pharmacopeia, and regulatory requirements (Food and Drug Administration and cGMP) preferred., • Experience with microbiological method development and method validation procedures like Sterility Testing, Endotoxin Testing, Disinfectant Efficacy Study, Water Testing, Method Validation, Environment Monitoring, Microbial Limit Testing, PET, and microbiological hold time validation, container closure integrity. Benefits: • Pay range $80,000-$85,000 per Year, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Job DescriptionAbout Rainmaker Rainmaker is pioneering a modern cloud seeding system to address water scarcity and inclement weather challenges worldwide. We develop and integrate radar validation, weather-resistant UAS, numerical weather modeling, and sustainable seeding agents into an effective precipitation enhancement solution. Rainmaker is building something that hasn't existed before. If you're the kind of person who gets energized by hard problems, new territory, and the opportunity to lead programs that have real impact on water resources, we want to hear from you. About the Role The Department of Field Operations is hiring Program Managers across multiple regions in the United States and internationally to lead cloud seeding operations on behalf of commercial and research interests. The Program Manager plays a critical role at Rainmaker, leading the design, planning, and execution of one or more cloud seeding programs from contract handoff through operational delivery. This person will work closely with the Government Affairs team to translate contracts and stakeholder interests into fully operational programs, then lead multi-disciplinary teams of Senior Operators, Field Operation Specialists, Forward Deployed Engineers, and Field Instrumentation Specialists through execution. This is a role for someone who thrives in constantly changing environments, solves hard problems creatively, and can lead both people and programs across challenging terrain, conditions, and obstacles with minimal guidance. Mission The Program Manager exists to grow Rainmaker's presence and impact in their region by sitting at the intersection of business development, government affairs, and field operations. Embedded in the communities where their programs operate, the Program Manager is uniquely positioned to build relationships with local stakeholders and translate those relationships into operational programs. In doing so, they are expected to continuously challenge and improve how Rainmaker designs and executes cloud seeding operations, bringing frontline knowledge and stakeholder insight back into the way we build program-s from the ground up. Responsibilities Program Execution Lead the end-to-end design, planning, and execution of one or more cloud seeding programs, delivering measured and meaningful precipitation enhancement to target regions Partner with the Government Affairs team to transition contracts and stakeholder commitments into operational program plans Manage and lead cross-functional field teams including Senior Operators, Field Operation Specialists, Forward Deployed Engineers, and Field Instrumentation Specialists Solve complex operational challenges driven by remote terrain, adverse weather conditions, and logistical constraints Own stakeholder reporting and internal program reporting throughout the operational season Plan and coordinate complex program logistics and resources Program Development & Business Growth During program offseasons, lead efforts to build out future programs, including site selection, operational planning, and logistics Cultivate and deepen relationships with existing stakeholders to expand program scope and introduce new opportunities Support business development efforts by identifying and pursuing new commercial and research program interests Qualifications Required Demonstrated ability to lead teams in challenging environments Strong problem-solving skills with a bias toward creative, unconventional solutions Excellent interpersonal and communication skills, with the ability to build trust across stakeholders, partners, and internal teams Self-directed and comfortable operating with minimal guidance Meticulous attention to detail in planning and execution Willingness to work in remote and physically demanding environments Preferred Experience in operational or logistical planning (military, aviation, emergency management, or similar fields) Experience in business development, sales, or client-facing relationship management Experience managing programs or projects with multiple concurrent workstreams across distributed locations Bachelor's degree in a relevant field (e.g., atmospheric science, environmental science, engineering, aviation, business, or related discipline) Comfort with frequent travel, including to remote or international locations Experience with GIS tools and spatial data (e.g., ArcGIS, QGIS, Google Earth) FAA Part 107 Remote Pilot Certificate Rainmaker participates in E-Verify. To learn more, including your rights and responsibilities, please visit E-Verify.gov. Rainmaker is an Equal Opportunity Employer; employment with Rainmaker is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability or any other legally protected status. No recruiting agencies.

Job DescriptionJob Title: Automation Engineer Job Description The Automation Engineer is responsible for ensuring the reliable operation of sterile pharmaceutical manufacturing systems. This role involves installing, maintaining, calibrating, and troubleshooting various automation components, process instrumentation, drives, motors, control devices, clean utility systems, and aseptic production equipment. The engineer will support continuous and compliant operations adhering to cGMP, FDA 21 CFR Part 11, and cleanroom standards. Responsibilities • Install, maintain, calibrate, and troubleshoot sensors and transmitters for pressure, temperature, flow, level, pH, conductivity, and environmental monitoring., • Support GMP-compliant calibrations with complete traceability and accurate documentation., • Install, maintain, and troubleshoot motors, pumps, fans, drives, control devices, and sterile manufacturing equipment., • Perform conduit bending, cable routing, wire pulling, cable termination, tray installation, and equipment connections in accordance with plant procedures., • Install and modify control panels, junction boxes, and instrumentation assemblies., • Diagnose issues in circuits, protection components, sensors, actuators, drives, and automated machines., • Use diagnostic tools such as multimeters, clamp meters, insulation testers, and calibration instruments., • Support PLC, HMI, SCADA, BMS, and EMS platforms, including troubleshooting and system checks., • Conduct loop checks, functional tests, FAT/SAT, commissioning, and support validation activities (IQ/OQ/PQ)., • Maintain and troubleshoot systems for PW, WFI, Clean Steam, CIP/SIP, HVAC/HEPA controls, and aseptic filling/packaging operations., • Read and interpret P&IDs, wiring diagrams, schematics, ladder logic, and loop drawings., • Maintain cleanroom support systems, including differential pressure controls, HEPA filtration, and environmental monitoring., • Ensure compliance with cGMP, cleanroom classification requirements, FDA 21 CFR Part 11, and data integrity principles., • Perform preventive, corrective, and predictive maintenance., • Conduct root-cause analysis and implement CAPA actions., • Maintain accurate CMMS entries, calibration logs, and audit-ready documentation.Essential Skills, • Strong troubleshooting skills across sensors, transmitters, motors, drives, actuators, control components, automated machinery, and process systems., • Experience with conduit bending, tray installation, cable pulling, wire routing, cable dressing, and termination., • Proficiency in installing and modifying panels, junction boxes, and equipment assemblies., • Skilled in using multimeters, clamp meters, insulation testers, and calibration devices., • Ability to install, connect, and terminate control wiring and instrument cabling for field devices., • Understanding of circuits, drives, starters, protection components, actuators, and control system diagnostics., • Ability to read and interpret P&IDs, schematics, wiring diagrams, ladder logic, and loop documentation., • Knowledge of GMP requirements, sterile manufacturing, cleanroom practices, aseptic operations, and validation processes., • Strong documentation discipline, attention to detail, and audit readiness., • Ability to work efficiently and safely in regulated manufacturing environments.Additional Skills & Qualifications, • Minimum 3 to 10 years of professional experience in the field of pharmaceutical or manufacturing industry., • Degree in Mechanical or Chemical Engineering from a reputed university., • Result-oriented with innovative thinking., • Strong time management and professional work conduct., • Problem-solving ability with a high level of interpersonal relationship skills., • Strong written and verbal communication skills., • Must have experience in pharmaceutical manufacturing., • Valid driver's license and acceptable driving record., • Legally authorized to be employed in the United States., • Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles' radius).Work Environment The role requires the ability to work rotating, weekend, or extended shifts. The work environment includes exposure to high-noise areas with PPE provided, frequent work on mezzanine floors, elevated platforms, ladders, and step-ups. You will work inside aseptic cleanrooms and controlled environments (ISO 5/7/8) wearing full gowning. Exposure to hot, cold, humid, or pressurized utility systems such as PW, WFI, Clean Steam, and HVAC units is expected. Occasional work in tight spaces, behind panels, or equipment enclosures may be required. Regular use of PPE, including sterile gowning, gloves, and eye protection, is mandatory. The role also demands the ability to lift up to 50 lbs and perform hands-on tasks for extended periods. Job Type & Location This is a Permanent position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $75000.00 - $95000.00/yr. Health dental vision 401k holiday pay and pto Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on Jun 5, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Job Description EHR/IT Applications Trainer Department/Care Stream: IT LIA Reporting Structure Timecard Approver: Director of EHR Training Development Primary: Director of EHR Training Development Secondary: Director of EHR Training Development Status: Full-Time FLSA: Exempt Location: Admin Center Pay Range: $87,360-$108,500 EEO-1: Technician Organization Information WellSpace's mission is "achieving regional health through high quality comprehensive care." We believe that everyone deserves to be seen, no matter who you are, where you come from, where you work or what place you call home. At WellSpace, we see you! We are driven to serve the whole person through comprehensive, integrated care, spanning medical, dental, behavioral health, and supportive services across the region. We do this by building a team of exceptional colleagues who are dedicated to our mission and becoming part of the communities we serve. As the region's largest Community Health System, WellSpace utilizes a Confluence Model to integrate an internal network of healthcare modalities, including Federally Qualified Health Centers (FQHC), Certified Community Behavioral Health Center (CCBHC), Drug Medi-Cal and Specialty Mental Health programs, California's second largest 988 Suicide and Crisis Lifeline Center, an independent Risk Bearing Organization (WellSpace Nexus), and more into a seamless confluence of care. To ensure the highest quality of care, WellSpace is accredited by the Joint Commission for Ambulatory Care, Behavioral Health and as a CCBHC. Further, it is certified by the Joint Commission as a Primary Care Medical Home and a Behavioral Health Home. WellSpace's crisis programs are accredited by the American Association of Suicidology and the International Council for Helplines. Position Summary The EHR/IT Applications Trainer is responsible for the training, implementation support, and ongoing optimization of enterprise-level healthcare software applications, primarily the Electronic Health Record (EHR) and Electronic Practice Management (EPM) systems. This position serves as a key liaison between clinical/administrative end users and IT, ensuring smooth onboarding, training, and support for all EHR-related functionality. In addition to training responsibilities, this role includes duties commonly assigned to an application support specialist or system analyst—such as building and maintaining training environments, validating workflows against live system builds, and participating in the design and testing of new workflows and configurations. The trainer must have a working knowledge of how to use the EHR and be familiar with its functionalities to guide users through optimized workflows and resolve system-related issues in collaboration with informatics and technical teams. Required Qualifications · Bachelor's degree in an academic or scientific field related to Information/ Systems Management or Technology, or the equivalent in training and experience. · Minimum of one (1) year work experience in Electronic Health Records systems and training of providers and clinical staff support in these systems and other clinical support functions. • Fluency in additional languages preferred. · Experience working with Federally Qualified Health Centers (FQHCs) and their specific patient populations is preferred. · Demonstrate leadership skills and be able to work collaboratively with others in a team environment, respecting and valuing the perspectives and experiences of others. · Strong customer service, project management skills, or consulting experience. · Knowledge of applicable data privacy practices and laws. · Initiate and complete work without direct supervision. Requires the ability to work effectively under pressure. · Experience working with diverse communities in a non-profit or healthcare setting. · Sensitivity to the needs of culturally and linguistically diverse patients and employee population. · Demonstrated ability to analyze functional and technical requirements and translate these into valid solutions; Knowledge of primary care clinic workflow and/or other healthcare experience is a plus. · Ability to communicate clearly in order to facilitate the understanding of issues involving technical matters to persons not well-versed in technology and information systems. Excellent written and verbal communication skills required. · Communicate clearly and concisely, both verbally and in writing and demonstrate a high level of listening skills. · Skilled in Microsoft, including Word, Excel, PowerPoint, and Outlook. · Ability to tailor one’s teaching style to the individuals in the room. · Ability to be adaptable and resilient in a rapidly changing, innovative work environment. · Ability to champion the adoption of new workflows related to technology applications applicable to the organization. · Adherence to infection control procedures, including but not limited to, standard precautions of temperature monitoring, hand washing, symptom self-monitoring, masking and social distancing. · Assist and support the Center/Department/Program to meet standards of High Reliability. Essential Responsibilities and Duties · Manages the delivery of training in both formal (e.g., classroom), and informal (e.g. in clinic) settings. · Coordinates with the training team and the IT Training and Development manager to effectively schedule and train new clinical/administrative staff on her and IT applications. · Conducts train-the-trainer sessions on the EHR and other acquired/updated software. · Provides Help Desk technical support to end-users based on assigned tickets and telephone calls. · Reviews and assists in the development of training documentation and ensuring this documentation is easily accessible to all end-users of the organization. · Works to disseminate information vital to user functionality in a manner that is easy to absorb, in layperson terms. · Promotes the importance of proper use of applications with an emphasis on optimum workflow. · Develops FAQs on relevant applications based on user feedback. · Actively participates in team-based planning for the Information Technology group, providing timely and relevant feedback on EHR/EPM and applications usage to inform future rollouts and implementations. · Attends meetings and trainings as assigned. · Provides post-production support for end users, including reinforcement work sessions, departmental rounding, and on-the-job refresher in-services. · Participates in application testing, simulations, and go-live activities, including production support of new projects or production enhancements. · Participates in on-site support after system implementation, application enhancements, and system upgrades. · Presents on implementation and training of EHR/EPM and other relevant IT applications to various workgroups, both internal and external. · Coordinates with technical staff to troubleshoot and resolve issue tickets reported by users. Communicates resolution to end users. · Provides consultative services to clinical users. · Creates and maintains training environments, including mock patient records, scenarios, and test scripts. · Participates in system design reviews to assess training implications and contributes to workflow testing and validation. · Collaborates with operational and technical teams to align training with real-time system configuration. · Supports system users by resolving EHR-related issues and escalating complex problems as needed. · Provides structured feedback to the informatics team based on end-user experience. · Participates in go-live planning, command center support, and ticket triage during system changes or deployments. · Ensures accurate documentation of training completion to support compliance and readiness for audits. · Maintains training and knowledge base repositories in accessible formats for learner reference. · Familiarity with the functionalities of the Electronic Health Record system; includes understanding clinical and administrative workflows, user navigation, documentation tools, and order entry, as well as having the ability to guide users through these functions effectively. · Maintains confidentiality regarding privileged proprietary, administrative, technical and clinical information according to HIPAA and quality of care standards; ensure system security to meet data confidentiality requirements. · Performs other duties as assigned. Benefits The successful candidate will receive a regionally competitive salary, above-average health benefits at reduced costs, company-paid life insurance & long-term disability insurance, an additional voluntary retirement plan with company match, and no vesting schedule requirement. · Paid bereavement and jury duty leave · 11 paid holidays per year · Paid time off · Paid sick leave · Flexible Spending Program · Company paid malpractice insurance for all providers · Professional development hours offered annually Physical Demands and Work Environment The work environment is characteristic of an office environment. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; use hands and arms to reach. The employee is also required to stand; walk; and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and the ability to adjust focus. The employee must also possess hearing and speech to communicate in person and over the phone. The noise level in the work environment is usually quiet. The employee may be in contact with individuals and families in crisis who may be ill, using substances and/or not attentive to personal health and safety for themselves or their homes. The employee may experience a number of unpleasant sensory demands associated with the client’s use of alcohol and drugs, and the lack of personal care. The employee may also be exposed to bodily fluids (blood, urine) and hazardous chemicals. WellSpace Health is committed to the principles of equal employment. We are committed to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is the intent of WellSpace Health to maintain a work environment free of harassment, discrimination, or retaliation because of age, race, religious creed, color, national origin, ancestry, physical disability, medical condition, genetic information, marital status, sex (including pregnancy, childbirth, breastfeeding and/or related medical conditions), gender, gender identity, gender expression, sexual orientation, military or veteran status, or any other status protected by federal, state or local laws. WellSpace Health is dedicated to the fulfillment of this policy in regard to all aspects of employment, including but not limited to recruiting, hiring, placement transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. WellSpace Health is an Equal Opportunity Employer Company DescriptionWellSpace's mission is "achieving regional health through high quality comprehensive care." We believe that everyone deserves to be seen, no matter who you are, where you come from, where you work or what place you call home. At WellSpace, we see you! We are driven to serve the whole person through comprehensive, integrated care, spanning medical, dental, behavioral health, and supportive services across the region. We do this by building a team of exceptional colleagues who are dedicated to our mission and becoming part of the communities we serve. As the region's largest Community Health System, WellSpace utilizes a Confluence Model to integrate an internal network of healthcare modalities, including Federally Qualified Health Centers (FQHC), Certified Community Behavioral Health Center (CCBHC), Drug Medi-Cal and Specialty Mental Health programs, California's second largest 988 Suicide and Crisis Lifeline Center, an independent Risk Bearing Organization (WellSpace Nexus), and more into a seamless confluence of care. To ensure the highest quality of care, WellSpace is accredited by the Joint Commission for Ambulatory Care, Behavioral Health and as a CCBHC. Further, it is certified by the Joint Commission as a Primary Care Medical Home and a Behavioral Health Home. WellSpace's crisis programs are accredited by the American Association of Suicidology and the International Council for Helplines.WellSpace's mission is "achieving regional health through high quality comprehensive care." We believe that everyone deserves to be seen, no matter who you are, where you come from, where you work or what place you call home. At WellSpace, we see you! \r\n\r\nWe are driven to serve the whole person through comprehensive, integrated care, spanning medical, dental, behavioral health, and supportive services across the region. We do this by building a team of exceptional colleagues who are dedicated to our mission and becoming part of the communities we serve. \r\n\r\nAs the region's largest Community Health System, WellSpace utilizes a Confluence Model to integrate an internal network of healthcare modalities, including Federally Qualified Health Centers (FQHC), Certified Community Behavioral Health Center (CCBHC), Drug Medi-Cal and Specialty Mental Health programs, California's second largest 988 Suicide and Crisis Lifeline Center, an independent Risk Bearing Organization (WellSpace Nexus), and more into a seamless confluence of care. \r\n\r\nTo ensure the highest quality of care, WellSpace is accredited by the Joint Commission for Ambulatory Care, Behavioral Health and as a CCBHC. Further, it is certified by the Joint Commission as a Primary Care Medical Home and a Behavioral Health Home. WellSpace's crisis programs are accredited by the American Association of Suicidology and the International Council for Helplines.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals LLC, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: Title of the Position: Visual Inspection and Packing Operator At Nivagen, the Visual Inspection and Packaging Operator plays a critical role for performing manual visual inspection of products to ensure that defined quality standards are met. The role also involves operating manual and/or automatic leak testing machines and packing equipment to prepare products for shipment. The operator must perform activities related to sterile manufacturing, as and when required, and ensure that all operations are carried out in strict compliance with company policies, standard operating procedures, applicable regulatory requirements, and current Good Manufacturing Practices (cGMP), while upholding the highest standards of product quality and safety throughout the production process. Responsibilities: • To perform the visual inspection of the filled containers manually i.e., vials (liquid and lyophilised), pre-filled syringes, cartridges and IV bags., • To identify the defects i.e., Volume variation, particulate matter (such as glass pieces, any type of particles, fibres, etc.) Cosmetic defects (such as cap defects, sealing defects, label flaws, printed text matter flaws, external contamination, damage, wrong labelling, cross labelling flaws etc.) and shall ensure no defective product shall be supplied to the market., • Reconciliation and Segregation of the good and defective containers, preparation of defect library and preparation of Knapp/qualification kits required for the qualification of automatic inspection machines., • Assist and prepare documents (includes SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment., • Responsible for handling, collection, transportation,and storage of the semi-finished and finished products as per product storage conditions and as per process requirements., • Responsible for avoiding cross-contamination and mix-up errors at various stages of operations., • Responsible for collaborating effectively with cross-functional departments to ensure timely coordination and organization of all prerequisites, supporting the smooth operation of the department and ensuring the delivery of finished products that meet market needs and business demands., • Qualification/validation of the equipment and area in accordance with approved protocols, and preparation and readiness for the routine commercial manufacturing., • The role requires the ability to stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties., • The role requires good eyesight, strong attention to detail, the ability to identify defects or discrepancies, and a basic understanding of visual inspection and packaging requirements., • To perform in process, check and record details in documents in accordance with approved protocols, batch records, SOPs and regulatory guidelines., • Collaborate closely with production staff, including operators, supervisors, and cross-functional teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required., • Packaging of products with secondary packing materials and packing them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy., • Perform various packaging operations such as labelling of carton/pouch, carton/pouch packaging, weighing of carton /pouch, printing and verification of batch details on carton/pouch, tertiary packaging as per packaging configuration and standards., • Collaboration with warehouse, production, In process quality teams for timely support and product deliverables to meet OTIF., • Adhere to safety guidelines, promptly report hazards or accidents, and ensure the work area remains clean and organized., • Involved in daily operations, including cleaning, maintaining logs, and overseeing routine visual /packing activities to ensure efficiency and compliance, • Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans, • Assist and Managing market complaints, conducting investigations, implementing corrective actions, and preventing future occurrences., • Inventory management for the consumables required for the day to day packing activities., • Handling of Autoclave, Isolator and Filling machine as and when required., • Must be aware of clean room gowning., • Any other duties as directed by the supervisor. Education: • High school diploma or equivalent required; technical certification or degree in a related field is a plus. Experience: • 1-3 years of experience in pharmaceutical manufacturing, visual inspection, or packaging Knowledge and Skills: • cGMP, FDA regulations, and SOPs related to sterile and non-sterile pharmaceutical production., • Strong attention to detail and ability to detect visual defects., • Proficiency in operating inspection and packaging equipment., • Ability to follow written instructions and complete documentation accurately., • Good communication and teamwork skills. Requirements: • Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents), • Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius), • Able to successfully complete a drug and background check, • Stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties., • Must comply with cleanroom protocols, gowning, and PPE requirements., • The role requires strong attention to detail, the ability to identify defects or discrepancies, a basic understanding of quality control and packaging requirements, the capacity to work efficiently in a fast-paced environment while maintaining high standards, and good manual dexterity for handling delicate products. Benefits: • Pay range $18 - $25 per hour, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including medical, dental and vision coverage, • Paid time off plan, • 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job DescriptionCompany Description Transforming Life Science Consulting Worldwide. Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health. With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions. Focused on S/4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake. Grounded in our commitment to fast and intelligent decision-making, our client-first and open-hearted approach defines our ethos. With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality. At Fusion, we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients. Job Description We're looking for an experienced Senior IT Project Manager specializing in SAP integrations to join our organization. In this strategic role, you will lead complex SAP implementation and integration projects, specifically focusing on Laboratory Information Management Systems (LIMS) and Manufacturing Execution Systems (MES). You will drive project success through meticulous planning, analytical problem-solving, and decisive leadership while ensuring compliance with pharmaceutical industry standards and regulatory requirements. • Lead end-to-end SAP integration projects for LIMS and MES systems, managing scope, timeline, budget, and resource allocation, • Develop comprehensive project plans, risk assessments, and mitigation strategies aligned with organizational objectives, • Collaborate with cross-functional teams including IT, operations, quality assurance, and business stakeholders to define requirements and ensure successful implementation, • Analyze complex business processes and design optimized SAP integration solutions that enhance operational efficiency, • Oversee vendor management, contract negotiations, and performance monitoring throughout project lifecycle, • Ensure all implementations comply with FDA regulations, GxP guidelines, and pharmaceutical industry best practices, • Conduct stakeholder communication and manage expectations through regular status updates and executive reporting, • Identify and resolve technical and operational challenges with a detail-oriented, analytical approach, • Mentor and guide project team members, fostering a collaborative and high-performing environment, • Document project deliverables, lessons learned, and best practices for organizational knowledge management, • Manage system testing, validation, and user acceptance testing (UAT) protocolsQualifications, • 8+ years of professional experience in IT project management, with demonstrated success leading enterprise-level initiatives, • 5+ years of hands-on experience with SAP implementations and system integrations, • 3+ years of specific experience with LIMS and/or MES integrations in a pharmaceutical or life sciences environment, • Proven expertise in SAP configuration, customization, and module integration, • Strong knowledge of pharmaceutical regulatory requirements, including FDA compliance and GxP standards, • Proficiency in project management methodologies such as PMP, Agile, or Waterfall, • Advanced analytical and problem-solving skills with strong organizational and time management capabilities, • Demonstrated leadership experience managing cross-functional teams and external vendors, • Strong communication and interpersonal skills with the ability to influence stakeholders at all organizational levels, • Experience with data integration, ETL processes, and system architecture design, • Preferred: Project Management Professional (PMP) certification or equivalent credential Additional Information WHY YOU SHOULD JOIN FUSION: At Fusion, you’ll join a diverse team of talented professionals from around the world, united by a passion for delivering impactful digital transformation in the life sciences industry. You’ll be part of a flat-structured, collaborative organization where decisions are made efficiently, and your expertise directly shapes client outcomes. You’ll work alongside experienced consultants on complex, meaningful projects that demand both precision and innovation. Our culture emphasizes continuous learning, open knowledge sharing, and cross-functional teamwork—empowering you to grow both professionally and personally. Joining Fusion means becoming part of a company that: • Builds strong, trusted partnerships with clients, delivering tailored solutions that create real business value., • Drives delivery excellence, holding ourselves accountable for the quality and impact of every outcome., • Encourages entrepreneurial thinking, empowering you to take initiative, solve problems, and lead change., • Operates with a truly global mindset, where diverse perspectives, cultures, and collaboration fuel our success. WHAT WE OFFER - FUSION BENEFITS We’ve designed our benefits to support your growth, well-being, and global mobility. Growth & Development • Invest in Your Learning: Access annual budget for professional development., • Grow Your Skills: Join regular workshops and trainings to strengthen technical and soft skills., • Advance Continuously: Build the mindset, confidence, and capabilities to grow your career on your terms., • Shape an Inclusive Culture: Thrive in a workplace where your individuality is valued, and your voice drives meaningful change. Recognition & Reward • Earn What You’re Worth: Receive a competitive salary and benefits package that reflects your impact., • Refer Talent: Get rewarded for recommending new hires through our referral program., • Stay Rewarded: Access loyalty-based benefits starting from your third year via the Unity Scheme. Global Mobility & Local Support • Navigate Global Moves: Get help with visas, permits, and international assignments., • Benefit Locally: Enjoy perks tailored to your country of residence., • Collaborate Globally: Work in a diverse, inclusive culture where global teamwork drives success

Job Description About the Company: Nivagen is a global company devoted to improving lives by developing high-quality, affordable generic prescription drugs and over-the-counter products for the North American market. For over a decade, we have remained committed to our core values of excellence, integrity, and respect for people. Our dedicated team works collaboratively to advance manufacturing, distribution, and quality control, taking a comprehensive approach to healthcare. Through vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and an unwavering focus on excellence, we continually strive to enhance medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and strong training and development programs. By investing in our workforce and nurturing a culture of growth and support, we empower our team to drive innovation and make a positive impact in healthcare. Our mission at Nivagen is clear: to improve lives by providing high-quality, affordable medications while upholding the highest standards of integrity and excellence. As a leader in pharmaceutical manufacturing, Nivagen is committed to producing sterile products that meet the healthcare industry's rigorous demands. Specializing in the production of vials, pre-filled syringes (PFS), and IV bags, we aim to make a meaningful impact on patient care. Join our team to help push the boundaries of sterile manufacturing, achieving the highest standards in safety, quality, and operational efficiency. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Director of Quality Control Department: Quality Control Reports to: Head of Quality The Director of Quality Control leads all QC operations within a pharmaceutical manufacturing facility, ensuring reliable, compliant testing that meets regulatory expectations and supports timely product release. This role oversees QC laboratories (chemistry, microbiology, analytical development support, raw materials, stability, and in-process testing), manages scientific and operational strategy, drives continuous improvement, and ensures data integrity and regulatory compliance across all laboratory activities. Responsibilities: Leadership & Management • Provide strategic leadership for QC teams, including chemistry, microbiology, stability, and raw materials testing., • Develop and mentor QC managers, supervisors, and analysts to ensure strong technical capability and compliance culture., • Establish resource plans, staffing, skills development, and succession planning., • Set performance expectations, conduct performance reviews, and manage career development. Laboratory Operations & Oversight • Direct day-to-day QC operations to support manufacturing schedules, ensuring on-time testing and release., • Oversee testing for raw materials, in-process samples, finished products, environmental monitoring, and stability programs., • Ensure proper functioning, maintenance, and qualification/calibration of all lab equipment., • Oversee sample management, laboratory workflows, and prioritization., • Implement robust OOS/OOT/OOE processes and drive investigations to scientifically sound conclusions. Regulatory Compliance & Quality Systems • Ensure all QC activities comply with cGMP, FDA/EMA/ICH guidelines, USP/EP/JV standards, and company SOPs., • Own and maintain quality systems related to laboratory operations, including:, • Change control, • Deviations and investigations, • CAPA management, • Document control, • Data integrity program, • Prepare for and lead QC aspects of regulatory inspections and internal/external audits., • Ensure laboratory data integrity practices meet ALCOA+ principles. Analytical Strategy & Method Management • Oversee method validation, verification, transfer, and lifecycle management activities., • Evaluate and implement new analytical technologies to improve QC reliability, efficiency, and scientific rigor., • Collaborate with R&D/Analytical Development to ensure smooth tech transfer of analytical methods and specifications., • Ensure the QC team supports process changes, comparability studies, and product lifecycle management. Stability Program Management • Oversee design, execution, and monitoring of stability studies in compliance with ICH guidelines., • Ensure timely stability testing and trend analysis to support expiry dating, regulatory filings, and ongoing product quality review. Quality Metrics & Continuous Improvement • Develop, track, and report quality metrics (e.g., OOS rate, lab investigation cycle time, test turnaround time, EM trends)., • Drive continuous improvement initiatives such as Lean lab practices, automation, and digitalization., • Optimize laboratory workflows for efficiency while maintaining compliance and data integrity. Cross-Functional Collaboration • Act as a QC subject matter expert in cross-functional teams, including QA, Manufacturing, Regulatory Affairs, Supply Chain, and R&D., • Participate in material/vendor qualification, change control reviews, and deviation boards., • Support regulatory submissions by providing QC data, summary reports, and responses to agency questions. Qualifications: Education/Experience: • Master's or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline preferred., • A bachelor's degree with extensive experience may be considered., • 10+ years of experience in QC within pharmaceutical or biopharmaceutical manufacturing., • 5+ years of leadership/management experience in a GMP laboratory setting., • Experience preparing for and hosting inspections by FDA, EMA, or other health authorities., • Strong background in analytical chemistry and/or microbiology., • Experience with method validation, QC automation, LIMS/ELN, and electronic data management systems. Knowledge, Skills, and Abilities: • Deep knowledge of cGMP, ICH guidelines, USP/EP, and regulatory expectations., • Strong scientific judgment and technical problem-solving skills., • Excellent leadership, communication, and interpersonal skills., • Ability to manage multiple priorities and drive timely execution., • Demonstrated ability to develop high-performing teams and a culture of quality and compliance. Requirements: • Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles' radius) Benefits: • Pay range: Competitive Salary Range $120k - $150k Annually, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being (Medical, dental, and vision coverage), • Paid time off plan, • 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job Description Job Title: Validation Engineer IQ/OQ/PQ Additional Skills & Qualifications • Experience in aseptic sterile fill manufacturing facilities., • Experience supporting early-stage manufacturing and start-up facilities, including scale-up environments., • Involvement in commissioning and qualification phases of new equipment and production lines., • Ability to operate effectively in a fast-paced, dynamic environment and adapt to changing priorities., • Strong problem-solving skills and a self-starter attitude., • Willingness to live in or relocate to the Sacramento metropolitan area., • Willingness to travel occasionally to manufacturing or vendor sites as needed., • Cleaning validation experience is considered a plus. Job Description The Validation Engineer supports sterile pharmaceutical manufacturing with a strong focus on aseptic sterile fill operations, automated equipment, and early-stage start-up and commissioning environments. This role ensures that manufacturing equipment, processes, utilities, and systems comply with cGMP and global regulatory requirements, including FDA, EMA, and ISO standards. The Validation Engineer leads and supports the full IQ/OQ/PQ validation lifecycle for sterile and automated equipment and works cross-functionally to establish and maintain a compliant validated state throughout early manufacturing and scale-up phases. Responsibilities • Lead and support the IQ/OQ/PQ validation lifecycle for sterile and automated equipment, including aseptic filling lines, isolators, autoclaves, HVAC systems, and related process equipment., • Execute equipment and process validation activities to ensure compliance with cGMP and applicable regulatory standards., • Support facility start-up, commissioning, and early-stage manufacturing activities for new and existing production lines., • Author, review, and approve validation protocols, test scripts, and validation reports with a high level of technical accuracy and clarity., • Use validation tools such as validators and temperature/relative humidity data loggers to perform qualification and validation testing., • Collaborate closely with Manufacturing, Quality, Engineering, and Automation teams to define validation strategies and maintain a validated state for equipment and processes., • Identify gaps in equipment and process validation, propose risk-based solutions, and drive continuous improvement initiatives., • Participate in commissioning and qualification activities for new equipment, utilities, and systems in sterile manufacturing operations., • Support investigations and corrective and preventive actions (CAPA) related to validation, equipment performance, and process deviations as needed., • Operate effectively in a fast-paced start-up or scale-up environment, taking ownership of assigned validation tasks and delivering on timelines., • Provide technical input on aseptic processing, sterile fill operations, and automated equipment during project planning and execution., • Ensure validation documentation is complete, accurate, audit-ready, and aligned with internal procedures and regulatory expectations. Essential Skills • Bachelor’s degree in engineering, life sciences, or a related field., • 3–5 years of experience in pharmaceutical validation, manufacturing, or process engineering, preferably in aseptic sterile fill facilities., • Hands-on experience with automated pharmaceutical manufacturing equipment and equipment process validation., • Experience supporting start-up and commissioning phases for new equipment and early-stage manufacturing environments., • Strong knowledge of cGMP requirements and global regulatory standards, including FDA, EMA, and ISO., • Demonstrated experience with validation documentation, including authoring and reviewing validation protocols and reports., • Experience working with validation tools such as validators and temperature/relative humidity data loggers., • Strong understanding of equipment and process validation in sterile manufacturing and aseptic processing operations., • Excellent technical writing skills with strong attention to detail., • Proven ability to work cross-functionally with Manufacturing, Quality, Engineering, and Automation teams., • Ability to work independently with minimal supervision and take ownership of assigned responsibilities., • Proactive mindset with the ability to identify gaps and drive improvements in validation and manufacturing processes. Work Environment The role is based in the Sacramento metropolitan area and supports sterile pharmaceutical manufacturing operations in a fast-paced, early-stage start-up or scale-up environment. The Validation Engineer works on-site in cGMP-controlled facilities that include aseptic sterile fill areas, automated filling lines, isolators, autoclaves, HVAC systems, and related process equipment. The position involves frequent collaboration with Manufacturing, Quality, Engineering, and Automation teams, as well as occasional travel to manufacturing or vendor sites. Work will regularly involve the use of validation tools such as validators and temperature/relative humidity data loggers, along with extensive preparation and review of technical documentation. The environment emphasizes regulatory compliance, technical rigor, and continuous improvement while offering opportunities to contribute directly to the successful start-up and validation of new sterile manufacturing capabilities. • This posting is for an existing vacancy. #LI-SC1 Job Type & Location This is a Permanent position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $90000.00 - $105000.00/yr. o Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being o Medical, dental and vision coverage o Paid time off plan o 401k savings plan Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on Jun 5, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Job Description Gurstel Law Firm, P.C. – Associate Attorney-Centralized Document Review JOB SUMMARY We are seeking a detail-oriented Associate Attorney with strong academic credentials to join our fast-paced, high-volume debt collection practice. The ideal candidate possesses a passion for collection law and thrives in a deadline-driven environment. This role focuses heavily on document review, regulatory compliance, and legal strategy within the consumer credit sector. DUTIES AND RESPONSIBILITIES • Compliance & Document Review: Review legal documents (Validation Notices, Affidavits, Notices of Intent, etc.) to ensure strict adherence to Federal and State regulatory laws and client-specific policies., • Legal Signing: Execute and sign documents in accordance with Firm Compliance procedures and State Attorney Review Requirements for licensed jurisdictions., • Litigation Support: Provide recommendations based on case law analysis; perform court appearances only as necessary in licensed states., • Strategic Planning: Assist in managing high volumes of information while maintaining quality control and strategic alignment with firm goals., • Adaptability: Position could include, as necessary, court appearances in the states in which the attorney is licensed and other duties as necessary and assigned. Duties, responsibilities, and activities may change at any time with or without notice., • Attend continuing education classes, webinars, and seminars to remain current and well-informed of any local, state, or federal changes in the law, rules of court or court procedures. QUALIFICATIONS AND SKILLS • No courtroom experience is necessary or required., • Education & Licensure: J.D. from an accredited law school and active membership in the State Bar with no disciplinary action., • Legal Knowledge: Strong understanding of federal, state, and local laws. Proficiency in FDCPA regulations and legal database software is highly preferred., • Experience: No courtroom experience is necessary or required. Background in civil litigation is desired. Advanced knowledge of bankruptcy law, consumer credit, or contract negotiation is a significant plus., • Technical Skills: Proficient in Microsoft Office Suite with strong legal research and analytical abilities., • Soft Skills: Exceptional oral and written communication; ability to collaborate effectively across all organizational levels., • Superior time management skills and ability to effectively manage priorities to meet business requirements and deadlines in a dynamic and fast paced environment., • Ability to communicate effectively across a broad spectrum of attorney and non-attorney recipients including all levels within the organization and external., • Ability to think globally by ways of strategic planning and risk management. COMPETENCIES • Accountability 20%, • Dependability 20%, • Communication 20%, • Compliance and Discipline 20%, • Ethics & Integrity 20% TRAVEL – This position requires travel to courts if needed. COMPENSATION AND BENEFITS • NO BILLABLE HOURS, • Medical, Dental, Vision, STD, LTD, Life, Accident, Critical Illness, Long-Term Care, Pet Insurance, 401k, Profit Sharing, and Student Debt Retirement Savings Program., • Flexible Time Off (FTO)/ Paid Holidays, • Professional yet casual work environment, • Bonus and Commission potential, • Paid CLE’s & Dues Gurstel Law Firm, P.C. (hereinafter “the Firm”) is multi-state litigation law firm representing creditors in all aspects of legal collection process. The Firm is headquartered in Golden Valley, Minnesota with offices in Arizona, California, Iowa, Minnesota, Nebraska, Nevada, Utah, and Wisconsin. Its practice is focused on the development of attorneys’ litigation skills, strategies and industry knowledge. CULTURE At Gurstel, we operate on our Core Values of Doing Right, Achieving Results, and Maintaining our Integrity. We champion diversity and are a very fast-paced, enthusiastic group of people! Success is celebrated and we are looking for people who share those same values with the drive to exceed expectations and think outside the box! Our culture is what makes our Firm a fun and rewarding place to work. EOE- Gurstel Law Firm, P.C. is an Equal Opportunity Employer (M/W/D/V) dedicated to diversity in the workplace and offers a great work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you are based in California, you can read information for California residents linked here

Job DescriptionDescription: What we do Wescom Solutions provides systems engineering, construction management, and operations support services to the rail transit industry. Our mission is to help transit authorities enhance their system capabilities, capital program execution and operational efficiencies in the safest, and most time- and cost-efficient manner. Why Wescom Solutions At Wescom Solutions we're not just offering a job; we're inviting you to be a crucial part of our dynamic culture. Here's why working with us is a unique and rewarding experience: Make a Real Impact: In a small business, your contributions don't get lost. You'll play a pivotal role in shaping our success from day one. Flexibility and Agility: Say goodbye to rigid structures. At Wescom Solutions, we embrace flexibility and adaptability, allowing you to thrive in a creative and dynamic work environment. Learning and Growth Opportunities: A small business is a breeding ground for learning. Expect to wear multiple hats, take on new challenges, and grow both personally and professionally. Direct Communication Channels: Skip the hierarchical ladder. Here, your ideas and suggestions are heard directly. Open communication is not just encouraged; it's essential to our success. Ready to be a part of something big in a small package? Apply now and help provide "Solutions for Tomorrow's Connections". Position Summary We are seeking a Overhead Contact System (OCS) Engineer who will be responsible for the design of systems for high-speed rail, commuter rail, light rail, streetcar, and electrified bus systems throughout the United States. This position can be based anywhere in California but will require the ability to travel when needed. The OCS Engineer will be part of the Systems Engineering team responsible for a variety of engineering tasks including, but not limited to planning, conceptual engineering, design, final engineering, constructability, and cost estimating. Essential Duties and Responsibilities • Design OCS layout, wire tensions, for light rail, commuter rail and streetcar with pantograph as well as electrified buses with trolley poles., • Generate design reports for all phases of system design for new OCS and modifications to existing systems., • Design layout plans, wire profiles, and support structures, including cantilevers, portals, head spans, OCS hardware and grounding and bonding., • Perform pole and foundation loading calculations, tension calculations, analysis of wire sag and rise conditions., • Perform technical review of other team members’ designs., • Ensure compliance with all federal, state & local regulations, • Participate in the implementation phase of projects, such as support for Planning, Scope Generation, Installation, Testing & Commissioning, Cutover, Record Drawings review and final reports., • Collaborate with other technical teams such as Traction Power, Communications, Signals & Train Control, Electrical, Mechanical, Structural, Architectural, Trackwork, and Civil; including coordination and design of interfaces., • Lead technical interactions with clients, operations, and other major stakeholders., • Support cost estimates, project schedules and budget forecasts., • Participate in project pursuit efforts., • Serve as a leader and provide guidance to junior team members, • Support the management of System Interfaces and creation of Interface Control Documents (ICDs)., • Support System Engineering and Assurance efforts such as Requirements Management, Verification & Validation, RAM, Safety Assurance, Quality Management, EMI/EMC, and others. Requirements: Qualifications (Knowledge, Skills, and Abilities) Minimum Requirements: • Bachelor Degree in relevant field and 4+ years of experience in OCS design for public transit rail projects Preferred Qualifications: • 6+ years of relevant experience and EIT with a goal of obtaining a Professional Engineer (PE) license., • Experience with OCS design, including the design of 600 to 1500 volt dc rail as well as 12 to 25 kilovolt AC, • Experience in OCS Testing & Commissioning, Cutover, Interface Management and Operations & Maintenance., • Working knowledge of codes and standards applicable to rail projects., • Accustomed to operating within a multi-disciplinary project structure with responsibility for OCS design., • Experience and knowledge of tension and pole/foundation load calculations., • AutoCAD or MicroStation experience., • Self-motivated and able to work independently with limited direct supervision., • Able to multitask due to concurrent projects., • Excellent communication and interpersonal skills in order to lead discussions with senior project staff, partners, clients and suppliers. Wescom Solutions is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Supervisor, Quality Control (QC) is responsible for overseeing daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out-of-specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness. We are multiple positions across the following schedules: Day Shift:• 6:00am to 6:30pm or• 6:30am to 7:00pm Night Shift:• 6:00pm to 6:30am or• 6:30pm to 7:00am Work Week Schedule:• Sunday, Monday, Tuesday + every other Wednesday or• Thursday, Friday, Saturday + every other WednesdayPhysical Demands • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.Essential Duties & Key Responsibilities, • Lab work and supervisor roles: Lead routine quality control testing on raw materials, process intermediates, and final cell therapy products. Supervise the QC team, supporting data verification, leading investigations, prioritizing tasks, and collaborating with other teams. Perform tests, ensure compliance, maintain the lab, prepare reagents, aliquot samples, assist with assay transfer/validation, train staff, and manage supplies., • Data Integrity and Audit Trail Review: Ensure GMP compliance by conducting audit trail reviews, identifying data integrity issues, and ensuring proper documentation. Lead and document QC testing results, and assist with preparing and reviewing batch records, SOPs, and related documentation to ensure adherence to cGMP regulations., • Investigations and CAPA: Oversee Quality System investigations into OOS results, atypical findings, and lab deviations. Ensure root cause analysis, documentation, and implementation of CAPAs, collaborating with cross-functional teams to resolve quality issues., • Lab Inspection Readiness: Monitor lab conditions to ensure compliance with cGMP and FDA/EMA regulations, maintaining documentation, equipment logs, and records for inspection readiness. Lead preparation activities for internal and external audits, including document reviews and mock audits., • Team Leadership and Oversight: Manage and support a team of QC analysts, overseeing scheduling, training, and performance evaluations. Provide technical guidance and mentorship to ensure high-quality, compliant practices., • Documentation and Reporting: Review and approve analytical data, protocols, and reports for accuracy and compliance. Maintain metrics for lab performance, deviations, investigations, and audit trail reviews., • Identify opportunities to improve lab operations, workflow efficiency, and compliance practices, and actively participate in revising and developing SOPs and policies., • Collaborate with cross-functional teams to ensure that external requests and activities align with site priorities., • Perform other duties as requested by supervisor/manager to support QualityStay current with industry regulations, standards, and best practices related to quality control., • Stay current with industry regulations, standards, and best practices related to quality control. Minimum Qualifications, • Bachelor’s degree in Chemistry, Biology, or a related scientific discipline (Master’s degree preferred)., • Minimum of 5 years of experience in a GMP-regulated QC laboratory, with at least 2 years in a supervisory or lead role., • Strong knowledge of cGMP, FDA, and ICH guidelines., • Proven experience conducting audit trail reviews and leading laboratory investigations., • Excellent organizational, analytical, and communication skills., • Ability to manage multiple priorities and work in a fast-paced environment.Night shift is eligible for a shift differential pay of +7%.The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Lab Technician - Document Writer Responsibilities: • Prepare, revise, and maintain analytical documents, including:, • Test methods and method validation protocols/reports, • Specifications, STPs, SOPs, control sheet, control work sheet and analytical procedures, • Change controls, deviations, CAPAs, and investigations, • Ensure documents comply with cGMP, FDA, ICH, and internal quality standards., • Manage document lifecycle activities using electronic quality systems., • Create and route documentation through approval workflows in TrackWise and eInfoTree., • Enter, review, and maintain analytical data and workflows in StarLIMS., • Collaborate with QC, QA, R&D, and Regulatory teams during document preparation and review., • Support internal and external audits by providing accurate and compliant documentation., • Maintain version control, archival, and traceability of analytical records., • Perform any additional tasks as assigned by management. Qualifications: Education/Experience: • High school/GED Degree. Knowledge, Skills, and Abilities: • Experience in assisting in preparing reports and writing documents., • Proficiency in Microsoft Office. Requirements: • Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $25 to $27 an hour, • Yearly bonus and stock options eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental, and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials. The QC Environmental Monitoring Technician is a crucial role in maintaining the integrity and safety ofour cell therapy products, conducting routine and non-routine testing to ensure the environmentalconditions in our cell therapy manufacturing facility meet the highest quality standards.The incumbent performs testing according to established operating procedures. Conducts routineenvironmental monitoring activities in the cell therapy manufacturing facility, including air and surfacemonitoring, to ensure compliance with regulatory requirements. Collects samples from critical areaswithin the manufacturing facility according to established procedures. Maintains and calibratesenvironmental monitoring equipment regularly to ensure accuracy and reliability of measurements.Maintains accurate and up-to-date records of environmental monitoring activities, including samplingplans, results, and corrective actions taken. Environmental analyses, including microbial and particulatematter testing. Performs basic lab functions like reagent preparation. 2nd Shift Hours Worked:• 1:00pm to 11:30pm Work Week Schedule:• Monday through ThursdayPhysical Demands • Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs., • Must be comfortable regularly participating in video-based meetings., • May be required to work scheduled overtime, weekends, or holidays based on business needs.Essential Duties & Key Responsibilities, • Perform a broad variety of basic and moderate complex tests in support of lab operations, • Perform testing of routine and non-routine samples and documents according to cGMP, • Perform routine lab and equipment maintenance, • Troubleshoot and address any equipment issues promptly to minimize downtime, • Prepare basic and complex reagents as assigned, • Order and maintain lab supply inventory, • Aliquot samples as required, including aseptic aliquoting, • Receive and provide training, • Perform other duties as requested by supervisor/manager to support Quality, • Collaborate with cross-functional teams, including manufacturing, quality control, and quality assurance, to address environmental monitoring-related issues and implement corrective actionsMinimum Experience, Education, Certifications, Licenses, • Prepare basic and complex reagents as assigned, • Order and maintain lab supply inventory, • Aliquot samples as required, including aseptic aliquoting, • Receive and provide training, • Participate in assay transfer and assay validation, • Perform equipment qualification/maintenance, • Identify and support resolution of technical problems, • Actively participate in group and project teamwork; project and process improvements, • Resolve issues as needed with management approval, • Adhere to cGMP policies and procedures, including documentation activities, • Perform other duties as requested by supervisor/manager to support Quality, • Willingness to work swing and night shifts2nd shift differential pay of +7% for non-exempt The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and post-marketing settings. In this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. About the Role As a Senior Physician in Patient Safety , you'll serve as the medical authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You'll collaborate with cross-functional teams, interact with clients, and contribute to the continuous improvement of our pharmacovigilance processes. Key Accountabilities: General Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee Interacting with internal and external stakeholders for resolving issues Attending and/ or presenting at client/cross functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs) Assisting the Project Lead/Functional Lead for audits and inspections Provides inputs for process improvements Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process Function as pharmacovigilance representative/safety scientist Attend/support Bid defense meetings Actively mentoring Patient Safety Physicians to develop their skills and expertise Case report medical review (as applicable) Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as require Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Review appropriateness of medical content in narrative for medical coherence Assessing seriousness, listedness / expectedness of reported events. Providing medical inputs to case processing team Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional) Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative Identify and resolve case issues, coordinate with client therapeutic/legal team Provide guidance to junior physicians on case assessment methodologies Periodic reports (as applicable) Reviewing and/ or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs Providing medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluation reports (HHEs), etc. Clinical Expert Statements and other documents as required Review reports assessed by junior team members for accuracy and completeness Medical monitoring (as applicable) Answering day to day medical and scientific questions, provide daily medical support to Parexel staff or site (investigator/study coordinator), as needed Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings) Provide medical safety expertise to client per request Review and sign off Data Management line listings (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication, efficacy end points), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities Review and sign off technical documents written by Parexel with respect to medically relevant matters with particular attention to those relating to patient safety Review coding of adverse events, medical history and concomitant medications for accuracy and consistency Review of patient profile report as needed Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors in conjunction with clients/sponsors or in conjunction with other Parexel departments Attend and present material as requested, at internal and external meetings (e.g., investigator meetings, therapeutic area training, Regulatory Authority meetings) Literature review (as applicable) Review of literature for product safety assessment and potential safety issues Expert in reviewing literature references including triaging, summarizing and providing MAH comments for aggregate reports and for various signal management activities CSR Narratives (as applicable) • Performing medical review of Clinical study report narratives according to the client's guidelines and SOPs Provide medical guidance to PV team/study team Provide medical guidance to safety staff during the case processing cycle Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs) Provide medical input into Pharmacovigilance workflows and projects as required On an as-needed basis, provide support in mentoring or training of new hired physicians Signal Detection and Management (as applicable) Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities Perform signal validation activities Author/review SERs. Perform case analysis, review literature summaries, check draft for medical and scientific accuracy and cohesiveness Author/review responses to HA requests and other safety documents Providing oversight and relevant inputs to Medical Writers (MWs) authoring SERs, Signal validations etc. Managing safety signals on project specific tools (e.g., Signal Tracking System, Signal management tools, etc.) Contribution to Safety Management Team (SMT) meetings: Data analysis/ review, content creation, presentation/ facilitation, drafting of meeting minutes Training and mentoring junior team members on signal detection methodologies Brand safety Physicians (as applicable) Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues Support the preparation and maintenance of Risk Management Plans Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels and Development Core Safety Information (DSCI) Coordinate safety activities between Drug Safety Unit/team and internal and external partners Conduct/support signal detection and evaluation according to SOPs and guidelines Prepare safety assessments, SERs, as necessary, for potential signals or issues (product quality) Perform review and summarization of literature citations including epidemiology background research Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents Contribute to regulatory agency submissions (Investigational new drug applications, new drug applications, Marketing authorization applications, Variations and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable Therapeutic Area Expert (as applicable) Serve as a subject matter expert within the designated Therapeutic Area, providing specialized knowledge to support drug safety initiatives and decision-making processes Collaborate with the TA Lead to implement strategic plans and enhance the overall expertise within the Therapeutic Area Contribute to the development and delivery of targeted training programs, elevating the knowledge base of fellow physicians and cross-functional teams Actively participate in internal and external scientific forums, representing Parexel's medical expertise through presentations, publications, and thought leadership activities Apply deep therapeutic knowledge to optimize pharmacovigilance processes, ensuring best practices are followed and continuously improved Mentor junior physicians within the TA, fostering their professional growth and encouraging their contributions to the field Support the TA Lead in identifying emerging trends and potential opportunities for innovation within the Therapeutic Area Engage in cross-functional projects, offering expert guidance to enhance the quality and efficiency of drug safety assessments Skills: Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date Demonstrated success in technical proficiency and scientific creativity Ability to work on complex tasks requiring in-depth evaluation Good knowledge of drug safety and the drug development process Ability to exercise judgment within broadly defined practices and policies Good presentation and verbal/written communication skills Good interpersonal skills Client focused approach to work Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps An ability to comprehend various regulatory or client requests and be able to strategize a handling approach Experience mentoring junior team members A flexible attitude with respect to work assignments and new learnings An ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail An ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential A willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including ICH GCP, GVP, and all other applicable regulations and guidelines Knowledge and Experience : US Board Certification/board eligibility or regional equivalent for Canada 3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required. Previous CRO experience is highly desirable, but individuals with relevant experience as a Patient Safety/Drug Safety Physician within Industry will also be considered. Good knowledge/understanding of medical terminology Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice Education: Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School Completion of at least basic training in clinical medicine (residency, internship etc.) This role offers the flexibility to work from home in either the US or Canada. #LI-KS1 #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Core Responsibilities • Provide support and maintenance for the EGrAMS Grants Database, • Perform day-to-day operations, issue resolution, and system support, • Support grant data workflows and reporting, • Ensure data accuracy, system performance, and availability, • Follow State processes, security, and compliance requirements Required Skillset • Database Support: SQL, data queries, data validation, • Application Support: Troubleshooting, incident management, • Data Management: Data integrity, reporting, basic analytics, • Tools/Environment: Experience with grants systems or enterprise applications (similar platforms acceptable), • Documentation: Ability to follow and maintain structured documentation Required Experience • 3–7+ years in application or database support roles, • Experience supporting data-driven or enterprise systems, • Experience working in structured environments (government or regulated preferred), • Proven ability to handle production support and user issues

About Us Since 1989, SHI International Corp. has helped organizations change the world through technology. We've grown every year since, and today we're proud to be a $16 billion global provider of IT solutions and services. Over 17,000 organizations worldwide rely on SHI's concierge approach to help them solve what's next. But the heartbeat of SHI is our employees - all 7,000 of them. If you join our team, you'll enjoy: Our commitment to diversity, as the largest minority- and woman-owned enterprise in the U.S. Continuous professional growth and leadership opportunities. Health, wellness, and financial benefits to offer peace of mind to you and your family. World-class facilities and the technology you need to thrive - in our offices or yours. Job Summary The SHI Services Solutions Engineer - Microsoft 365 Copilot and Copilot Studio Agents serves as a technical subject matter expert for Microsoft 365 Copilot and agent-based solutions, including declarative and custom engine agent proof of concepts (POCs). This role partners directly with customers and internal delivery teams to design, build, and govern AI-driven workplace experiences that deliver measurable business outcomes. This role focuses on the Microsoft 365 Copilot out-of-the-box experience, including technical deployment, leveraging Microsoft Graph data to assess tenant readiness, creating custom policies, identifying and preventing data oversharing, and enabling first-party agent capabilities. The role also supports declarative and custom engine agent development and enterprise governance of agents across Microsoft 365 Admin Center, Power Platform Admin Center, Azure, Microsoft Entra, Microsoft Purview, and Agent 365. The Solutions Engineer plays a key role in shaping solutions, accelerating service development, and ensuring consistent, secure, and scalable delivery across engagements. This position blends hands-on technical execution with design-led thinking, customer advisory skills, and a strong interest in applied AI across the modern workplace. This role sits at the intersection of AI innovation, human experience, and responsible AI enablement, offering the opportunity to shape how organizations build lasting capability with Microsoft 365 Copilot and workforce agents while contributing to the evolution of SHI's Microsoft Services practice. Role Description Copilot Experience and Agent Architecture Serve as the technical SME for Microsoft 365 Copilot deployment, extension, and agent solution development in Copilot Studio, including first-party, declarative, and custom engine agents Guide SHI customers through hands-on Microsoft 365 Copilot deployments, including tenant readiness assessments, data and AI readiness, license assignments, use case identification, and governance Lead end-to-end Copilot deployments, including prerequisite validation, service enablement, and rollout planning across Microsoft 365 Admin Center and related services Design and implement security and compliance controls using Microsoft Purview (labels, DLP, eDiscovery), Microsoft Defender (threat visibility), and Microsoft Entra (identity, conditional access, least privilege) Assess and reduce data exposure risks by analyzing Microsoft Graph signals, SharePoint and OneDrive permissions, sensitivity labels, and external sharing configurations Design and implement end-to-end agent solutions using Copilot Studio and the Power Platform, aligning workflows, automation, and extensibility to business needs Establish enterprise agent governance, including environment strategy (DEV/UAT/PROD), managed environments, ALM/pipelines, connector governance, solution packaging, auditing, and lifecycle management Configure Power Platform environments, including: DLP policies Managed environments and environment groups Environment rules and governance controls Power Platform pipelines for ALM, including approval flows Copilot Studio Kit installation and configuration Define agent architectures that balance out-of-the-box Copilot capabilities with custom logic, integrations, and automation patterns Implement secure, governed environments across identity, data access, compliance, monitoring, and lifecycle management Advise on best practices for Copilot adoption, governance, auditing, agent design, evaluation, observability, and operational readiness Collaborate with delivery teams to ensure solutions are scalable, supportable, and aligned to enterprise standards Develop and maintain technical assets, including reference architectures, design patterns, solution templates, and implementation guides Support customers in implementing Agent 365 to monitor, govern, and secure agent ecosystems Guide customers in exploring and adopting frontier capabilities, including Copilot Cowork and pre-built Microsoft agents Behaviors and Competencies Presenting: Can design and deliver engaging presentations, adapting the content and style to suit the audience, context, and medium. Negotiation: Can proactively seek out negotiation opportunities, initiate discussions, and contribute to conflict resolution. Communication: Can effectively communicate complex ideas and information to diverse audiences and can facilitate effective communication between others. Detail-Oriented: Can manage complex tasks or projects, identifying errors or inconsistencies, and ensuring all details are addressed, necessary corrections are made, and quality is maintained. Organization: Can effectively coordinate multiple projects, delegate tasks where appropriate, and employ advanced organizational tools and methods. Follow-Up: Can proactively identify tasks that require follow-up, initiate necessary actions, and contribute to efficient workflow management. Problem-Solving: Can proactively identify potential problems, initiate preventive measures, and propose and contribute to innovative solutions. Relationship Building: Can proactively seek out opportunities to expand networks, initiate collaborations, and contribute to team cohesion. Documentation: Can develop comprehensive documentation standards, implement best practices, and ensure documentation supports operational efficiency. Results Orientation: Can set challenging goals for their team and lead them to achieve these goals, demonstrating a consistent track record of results. Skill Level Requirements Hands-on experience with Microsoft 365 Copilot and Copilot Studio, including first-party agent capabilities Experience designing or implementing declarative and embedded agents using Power Platform (Power Apps, Power Automate, Power Fx, YAML) Strong understanding of agent architecture, governance, security, and lifecycle management using Microsoft Entra, Purview, Defender, and related services Demonstrated ability to act as a technical advisor and SME, guiding solution design and implementation Knowledge or interest in applied AI concepts such as prompt design, evaluation, monitoring, and responsible AI practices Familiarity with design-led or human-centered solution approaches Strong analytical and problem-solving skills with the ability to translate business needs into scalable technical solutions Excellent communication skills across technical and business audiences Commitment to continuous learning and staying current with Microsoft Copilot, agent, and AI platform evolution Preferred Certifications (or equivalent experience): Microsoft 365 Copilot and Agent Administration Fundamentals (AB-900) Power Platform Solutions Architect (PL-600) Microsoft Agentic AI Business Solutions Architect (AB-100) Microsoft Azure AI Engineer Associate (AI-102) Candidates are encouraged to apply even if they do not meet all listed qualifications. Other Requirements Bachelor's degree in a technical, business, or related field, or equivalent practical experience 4+ years of experience delivering solutions across Microsoft 365, Power Platform, Azure, or related Microsoft cloud technologies Ability to travel to SHI, partner, and customer events Ability to work independently while collaborating effectively with sales, delivery, engineering, and leadership stakeholders Strong ethical standards and adherence to data privacy, governance, compliance, and security policies Commitment to continuous learning across Microsoft Copilot, AI workloads, and adoption best practices The estimated annual pay range for this position is $150,000 - $207,000 which includes a base salary and bonus. The compensation for this position is dependent on job-related knowledge, skills, experience, and market location and, therefore, will vary from individual to individual. Benefits may include, but are not limited to, medical, vision, dental, 401K, and flexible spending. Equal Employment Opportunity - M/F/Disability/Protected Veteran Status

The Data Integration Analyst works as part of a fast-paced, deadline-driven team to ensure data is accurate, timely, and aligned with system and client requirements. Assist in testing, validation, and QA of data integrations and reporting outputs.

Job Description Job Title: IT Support & Systems Internship Company: X-Bow Systems Inc. Location: Sacramento, CA Duration: June 15 - August 15th 2026 Pay: 20.00$/HR About X-Bow Systems: X-Bow Systems Inc. (pronounced "Crossbow") is a U.S. defense technology and rocket propulsion company that has developed an innovative, low-cost method to manufacture solid rocket motors. Position Overview We are seeking a motivated IT intern to join our team and gain hands-on experience across cybersecurity compliance, operational technology (OT) modernization, and end-user support. This internship offers exposure to real-world IT infrastructure challenges in a manufacturing environment, with opportunities to work on CMMC compliance initiatives, OT network modernization, and technical support operations. Key ResponsibilitiesCMMC Compliance & Security (40%) • Assist with CMMC (Cybersecurity Maturity Model Certification) compliance initiatives and documentation, • Support backup and decommissioning of legacy Spencer systems and data, • Participate in risk assessments and mitigation planning activities, • Digitize paper records and maintain organized documentation, • Help develop and deliver end-user training and security awareness campaigns, • Identify and coordinate secure destruction of obsolete equipment and records, • Assist with kiosk deployment and provide end-user trainingOperational Technology (OT) Network Modernization (35%), • Support modernization of sensors, signals, and networks (DAC, Autoclave, WATLOW systems), • Assist with upgrading machining equipment controls (CNC, winders, microscopes, etc.), • Contribute to design of OT networked controls and monitoring systems, • Document processes and help establish Standard Operating Procedures (SOPs), • Create comprehensive mapping of OT assets and network topology, • Participate in testing and validation of OT security controls, • Identify process improvement opportunities and document findingsEnd-User Support (25%), • Receive, respond to, and perform initial triage of user support requests, • Promote proper ticketing workflow and escalation procedures with end-users, • Install and configure computers, printers, and peripheral devices, • Assist with software updates and patch management activities, • Create and update user guides and knowledge base articles, • Support specialized projects including vessel pressure testing and camera systemsLearning Objectives & Expectations CMMC & Cybersecurity Compliance • Gain exposure to CMMC framework, compliance requirements, and security best practices, • Learn to develop and implement compliance strategies under supervision of IT staff, • Understand risk management and security control implementation Operational Technology • Develop understanding of OT systems, industrial controls, and network design principles, • Learn to assess, plan, and implement technology modernization projects, • Gain experience with infrastructure mapping, documentation, and security testing End-User Support & IT Operations • Build foundational skills in IT troubleshooting and customer service, • Learn ticketing systems, escalation procedures, and support best practices, • Develop technical communication skills through user interaction and documentationQualifications Required: • Currently pursuing degree in Computer Science, Information Technology, Cybersecurity, or related field, • Strong interest in IT security, compliance, and operational technology, • Excellent communication and documentation skills, • Ability to work independently and as part of a team, • Detail-oriented with strong organizational skills Preferred: • Familiarity with cybersecurity frameworks (NIST, CMMC), • Basic understanding of networking concepts, • Experience with ticketing systems or help desk operations, • Interest in industrial/manufacturing technology environmentsWhat You'll Gain, • Real-world experience with CMMC compliance and cybersecurity frameworks, • Exposure to operational technology and industrial control systems, • Hands-on IT support and troubleshooting experience, • Mentorship from experienced IT professionals, • Understanding of IT operations in a manufacturing environment, • Professional development in documentation and process improvementWork Environment, • Manufacturing facility setting with both office and production floor exposure, • Collaborative team environment with direct mentorship, • Opportunities to work on diverse projects across multiple IT domains We are seeking a motivated IT intern to join our team and gain hands-on experience across cybersecurity compliance, operational technology (OT) modernization, and end-user support. This internship offers exposure to real-world IT infrastructure challenges in a manufacturing environment, with opportunities to work on CMMC compliance initiatives, OT network modernization, and technical support operations. Key ResponsibilitiesCMMC Compliance & Security (40%) • Assist with CMMC (Cybersecurity Maturity Model Certification) compliance initiatives and documentation, • Support backup and decommissioning of legacy Spencer systems and data, • Participate in risk assessments and mitigation planning activities, • Digitize paper records and maintain organized documentation, • Help develop and deliver end-user training and security awareness campaigns, • Identify and coordinate secure destruction of obsolete equipment and records, • Assist with kiosk deployment and provide end-user trainingOperational Technology (OT) Network Modernization (35%), • Support modernization of sensors, signals, and networks (DAC, Autoclave, WATLOW systems), • Assist with upgrading machining equipment controls (CNC, winders, microscopes, etc.), • Contribute to design of OT networked controls and monitoring systems, • Document processes and help establish Standard Operating Procedures (SOPs), • Create comprehensive mapping of OT assets and network topology, • Participate in testing and validation of OT security controls, • Identify process improvement opportunities and document findingsEnd-User Support (25%), • Receive, respond to, and perform initial triage of user support requests, • Promote proper ticketing workflow and escalation procedures with end-users, • Install and configure computers, printers, and peripheral devices, • Assist with software updates and patch management activities, • Create and update user guides and knowledge base articles, • Support specialized projects including vessel pressure testing and camera systemsLearning Objectives & Expectations CMMC & Cybersecurity Compliance • Gain exposure to CMMC framework, compliance requirements, and security best practices, • Learn to develop and implement compliance strategies under supervision of IT staff, • Understand risk management and security control implementation Operational Technology • Develop understanding of OT systems, industrial controls, and network design principles, • Learn to assess, plan, and implement technology modernization projects, • Gain experience with infrastructure mapping, documentation, and security testing End-User Support & IT Operations • Build foundational skills in IT troubleshooting and customer service, • Learn ticketing systems, escalation procedures, and support best practices, • Develop technical communication skills through user interaction and documentationQualifications Required: • Currently pursuing degree in Computer Science, Information Technology, Cybersecurity, or related field, • Strong interest in IT security, compliance, and operational technology, • Excellent communication and documentation skills, • Ability to work independently and as part of a team, • Detail-oriented with strong organizational skills Preferred: • Familiarity with cybersecurity frameworks (NIST, CMMC), • Basic understanding of networking concepts, • Experience with ticketing systems or help desk operations, • Interest in industrial/manufacturing technology environmentsWhat You'll Gain, • Real-world experience with CMMC compliance and cybersecurity frameworks, • Exposure to operational technology and industrial control systems, • Hands-on IT support and troubleshooting experience, • Mentorship from experienced IT professionals, • Understanding of IT operations in a manufacturing environment, • Professional development in documentation and process improvementWork Environment, • Manufacturing facility setting with both office and production floor exposure, • Collaborative team environment with direct mentorship, • Opportunities to work on diverse projects across multiple IT domains ITAR Requirements: To conform to U.S. Government space technology export regulations, including the International Traffic in Arms Regulations (ITAR), applicants must be a U.S. citizen, a lawful permanent resident of the U.S., a protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State Job Posted by ApplicantPro

Comfortable performing deep-tier validation including API testing (REST/GraphQL), SQL data verification, and monitoring cloud-native application health (AWS/Azure).

Write comprehensive testing, evaluation, and validation logic for machine learning pipeline components to ensure high reliability and product excellence.

At Serko, we believe something incredible happens when people come face-to-face.That’s why we’re on a mission to engineer a frictionless, next-generation business travel marketplace.We don’t just manage travel; we are leveraging advanced AI and cutting-edge tech to eliminate the complexity of

Senior Software Engineer — Development Team.Remote - Bay Area (Occasional Office Visits to Carmel, CA).Employer sponsored life insurance.Annual weeklong winter holiday break.Wellness Benefit through Holisticly.We're looking for a Senior Software Engineer to join our Development team — the core o

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of between $25/hr.There is no payment required in order to apply or to work as an In-Home Usage Tester.You do

RED Digital Cinema, a Nikon Group company, is a leading manufacturer of professional digital cameras.RED's modular camera system and groundbreaking image quality are by far the best on the market today! Started by Jim Jannard (founder of Oakley), RED continues to break ground with new products like