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Territory – Pacific Coast Target cities within the territory include San Francisco, Sacramento, Portland, Seattle, Boise, and Salt Lake City. The Pacific Coast territory includes Northern California, Oregon, Washington, and portions of Utah, Nevada, and Idaho. The Rare Epilepsy Market Lead is a strategic, field-based leader and local market expert responsible for engaging with key epilepsy Centers of Excellence (COEs) and rare epilepsy HCP treaters to identify barriers to treatment and provide appropriate disease state education, while compliantly promoting Onfi® (clobazam) and Sabril® (vigabatrin) across an assigned US Geography. Further, this role will be responsible for generating actionable insights, identifying local market opportunities, and compliant coordination with cross-functional stakeholders across Commercial, Medical, Advocacy, and Market Access as appropriate to strengthen disease awareness, patient understanding, and education across the ecosystem to advance Lundbeck’s mission to improve the lives of people living with rare and serious neurological conditions. PRIMARY DUTIES AND RESPONSIBILITIES • Serve as the primary local market expert, continuously assessing customer preferences and patient needs, treatment dynamics, access challenges, competitive activity, and emerging opportunities across the rare epilepsy ecosystem., • Develop and execute a comprehensive territory business plan aligned to national strategy while tailoring execution to local market dynamics., • Appropriately identify field-driven innovative solutions, including deployment models and executional plans based on local market dynamics, while maintaining alignment to BU strategies., • Provide appropriate education and educational resources on Developmental and Epileptic Encephalopathies (DEEs) and seizure disorders, including disease identification, patient journey, treatment considerations, and appropriate use of Onfi® and Sabril®, • Bridge local insights and enterprise strategy by leveraging a deep understanding of local epilepsy COEs, and treatment ecosystems to inform appropriate coordinated account engagement, • Develop awareness of, and appropriately engage with, local and regional patient advocacy organizations to support disease education, community engagement, and patient-centric initiatives in a compliant manner, • Demonstrate intellectual curiosity and a continuous learning mindset to uncover the underlying drivers of market dynamics and customer behavior, • Engage with epileptologists, pediatric neurologists, and neurology-focused advanced practice providers, and key COE and office personnel across the assigned territory to compliantly promote Onfi® and Sabril®, • Develop integrated account strategies that leverage the appropriate expertise and resources across Lundbeck to address complex challenges, • Appropriately operate as part of broader cross-functional organization and with other internal stakeholders, to ensure customer interactions are coordinated, purposeful, and aligned with account priorities and patient needs and broader commercial strategy, • Understand REMS program requirements and restricted distribution models associated with Sabril®, • In the future, potential to be responsible for management of, and collaboration across, a field-based team, • Utilize business analytics and CRM tools to track territory activity, account insights, and progress against business objectives, • Foster teamwork and a collaborative culture, champion and role model our Lundbeck rare epilepsy ways of working by empowering team members, acting with urgency, and orchestrating our customer experience to benefit the rare epilepsy patients and families we serve, • Ability to understand sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and appropriately communicates coverage changes to stakeholders, • Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products, • Accountability and adherence to corporate, FDA, and PDMA guidelines REQUIREMENTS • Bachelor’s degree from an accredited college or university, • 7+ years' experience in the pharmaceutical/biotech industry, • 3+ years of specialty sales experience in pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Demonstrated track record of performance in a complex, low-volume, high-science selling environment, • Ownership and accountability for the development and execution of fully integrated account plans, • Strong clinical and business acumen with the ability to engage credibly in scientific and medical discussions with specialist-level customers and key stakeholders across epilepsy centers, • Excellent communication, organizational, and cross-functional collaboration skills, • Strong understanding of patient and caregivers needs, purpose-driven with a demonstrated commitment to patient-centric engagement, • Demonstrated curiosity, adaptability and entrepreneurial mindset consistent with a lean, results-oriented commercial organization, • Self-directed with the ability to operate and thrive as an individual contributor with a mindset that embraces evolution & change, • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck, • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Must live within a state in the Pacific Coast territory or be state adjacent., • The role is part of Lundbeck’s Vehicle Fleet Stipend Program and requires business use of a personal vehicle. More information on the stipend program can be found _ PREFERRED QUALIFICATIONS • 2+ years in neurology, rare disease, or specialty CNS, • Prior experience in the epilepsy or rare neurological disease space strongly preferred, including rare disease product launch experience, • Prior experience professionally engaging with epileptologists or pediatric neurologists, • Experience with REMS programs or restricted distribution models, • Proficiency in CRM platforms and Microsoft Office Suite, • Prior commercial or sales leadership experience, • Market access payer experience, • Experience supporting specialty pharmacy/specialty distribution products, • Familiarity with academic health systems and referral networks, • Preference that candidate lives within 100 miles of the territory boundaries TRAVEL • Willingness/Ability to travel up to 70% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $190,000 - $230,000 and eligibility for a sales incentive target of $55,000 and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and Vehicle Fleet Stipend. Additional benefits information can be found on our _. Applications accepted on an ongoing basis.#LI-GK Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

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: Technician We are seeking a dedicated and experienced Technician to join our team at Nivagen. In this key role, you'll be responsible for operating and maintaining our HVAC system, BMS and EMS system ensuring they function safely, efficiently, and reliably. This position is pivotal in minimizing downtime and supporting our manufacturing operations' overall productivity and efficiency. Responsibilities: • Operate and maintain HVAC system , BMS, EMS and supporting areas observing all safety procedures and regulations., • Monitor HVAC systems to detect malfunctions and necessary maintenance., • Perform routine inspection and maintenance on HVAC systems to ensure optimal operation., • Record and maintain daily logs on HVAC operations, maintenance, and safety activities., • Coordinate with the maintenance team to implement repairs and improvements., • Adhere to all environmental policies and procedures, ensuring compliance with legal regulations., • Should have knowledge on the clean room classification , AHU zoning , pressure balancing and other operation related to AHU and its area of supply., • Preventative maintenance of HVAC systems, • Prepare the SOP / EOP for the system., • Ability to lean other system and operate them., • Follow Good documentation practices, • Any other duties as assigned by Supervisor Qualifications: Education/Experience: • High School Diploma or equivalent, • MUST HAVE Experience in handling HVAC systems, AHU's , outdoor units and supporting utilities in the pharmaceutical industry or related areas. Knowledge, Skills, and Abilities: • HVAC Systems & Components: Knowledge of heating, ventilation, air conditioning, refrigeration systems, and related components (furnaces, heat pumps, etc.)., • Electrical & Mechanical Expertise: Proficiency in wiring, circuit boards, motors, and other mechanical systems used in HVAC., • Troubleshooting & Diagnostics: Ability to efficiently diagnose and resolve HVAC system issues using diagnostic tools., • Installation, Repair, & Maintenance: Skilled in installing, repairing, and maintaining HVAC components and systems., • Customer Service & Communication: Strong skills in explaining issues and maintaining professional client relationships., • Energy Efficiency & Sustainability: Awareness of energy-efficient HVAC systems and eco-friendly practices., • Safety & Compliance: Knowledge of building codes, safety regulations, and adherence to industry standards (e.g., OSHA, EPA)., • Adaptability & Continuous Learning: Ability to work in varied conditions, learn new technologies, and stay updated with industry advancements. Requirements: • Valid driver's license and acceptable driving record, • Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents), • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Able to successfully complete a drug and background check, • Able and willing to walk, stoop, stand, bend, and lift throughout each shift, with or without accommodation Benefits: • Pay range $25.0 - $32.0 per hour (Based on Experience), • 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 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: Title of the Position: HVAC Technician We are seeking a dedicated and experienced HVAC Operator to join our team at Nivagen. In this key role, you'll be responsible for operating and maintaining our HVAC system, BMS and EMS system ensuring they function safely, efficiently, and reliably. This position is pivotal in minimizing downtime and supporting our manufacturing operations' overall productivity and efficiency. Responsibilities: • Operate and maintain HVAC system , BMS, EMS and supporting areas observing all safety procedures and regulations., • Monitor HVAC systems to detect malfunctions and necessary maintenance., • Perform routine inspection and maintenance on HVAC systems to ensure optimal operation., • Record and maintain daily logs on HVAC operations, maintenance, and safety activities., • Capable to perform repairs and improvements., • Adhere to all environmental policies and procedures, ensuring compliance with legal regulations., • Ability to replace / clean the different filter at HVAC side and also Clean room side like HEPA filter, pre filters etc, • Should have knowledge on the clean room classification , AHU zoning , pressure balancing and other operation related to AHU and its area of supply., • Preventative maintenance of HVAC systems, • Prepare the SOP / EOP for the system., • Ability to lean other system and operate them., • Follow Good documentation practices, • Any other duties as assigned by Supervisor Qualifications: Education/Experience: • High School Diploma or equivalent, • Experience in handling HVAC systems, AHU's , outdoor units and supporting utilities in a pharmaceutical industry or related areas. Knowledge, Skills, and Abilities: • HVAC Systems & Components: Knowledge of heating, ventilation, air conditioning, refrigeration systems, and related components (furnaces, heat pumps, etc.)., • Electrical & Mechanical Expertise: Proficiency in wiring, circuit boards, motors, and other mechanical systems used in HVAC., • Troubleshooting & Diagnostics: Ability to efficiently diagnose and resolve HVAC system issues using diagnostic tools., • Installation, Repair, & Maintenance: Skilled in installing, repairing, and maintaining HVAC components and systems., • Customer Service & Communication: Strong skills in explaining issues and maintaining professional client relationships., • Energy Efficiency & Sustainability: Awareness of energy-efficient HVAC systems and eco-friendly practices., • Safety & Compliance: Knowledge of building codes, safety regulations, and adherence to industry standards (e.g., OSHA, EPA)., • Adaptability & Continuous Learning: Ability to work in varied conditions, learn new technologies, and stay updated with industry advancements. Requirements: • Valid driver's license and acceptable driving record, • Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents), • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Able to successfully complete a drug and background check, • Able and willing to walk, stoop, stand, bend, and lift throughout each shift, with or without accommodation Benefits: • Pay range $25.00 - $30.00 per hour (Based on Experience), • 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 DescriptionBenefits: • 401(k), • Dental insurance, • Health insurance, • Paid time off STAR Long Term Care Pharmacy is a closed door pharmacy located in Sacramento, CA. We currently service Skilled nursing facilities. We are seeking an energetic pharmacist to join our team. RPH must have experience in LTC Pharmacy. We are looking for a Pharmacist with a flexible schedule and whom is eager to work in a small family environment. We offer competitive wages as well as benefits. If this position is what you are looking for please apply, we look forward to hearing from you and having you part of the team! Responsibilities: • Oversee the accurate preparation of medications for final dispensing to the patient, including order entry, filling, and toting., • Review filled blister cards and unit dose strips to ensure prescriptions are filled correctly., • Verify the legality and pharmaceutical feasibility of dispensing a drug based on patients' allergies, drug interactions, frequency of refills, etc., • Interpret prescription orders and exercise professional judgment in determining whether to dispense a particular prescription., • Transfer prescriptions to and from other pharmacies as needed., • Answer questions from patients, doctors, nurses, etc., • Oversee technicians in Compounding IV's., • Dose IV medications per patient specific data.Requirements: Must be licensed and in good standing in the state of CA, • Excellent Computer skills, • Excellent oral and written communication skills, • Excellent customer service skills, • Ability to problem solve, make decisions in a fast-paced environment, and meet deadlines, • Software experience preferred yet not required (Framework, DocuTrack), • Prior pharmacy experience preferredJob Types: Full-time, Part-time Benefits: • Dental insurance, • Health insurance, • Paid time off, • The ability to multitask and shift priorities, as needed

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. As a Regional Associate Director, you will be accountable for achieving Account Sales Objectives. You will build relationships with key accounts throughout the Area as defined by the Senior Area General Manager. Your role involves understanding and recommending the use of Kerendia in the appropriate patient type and identifying opportunities to expand business by aligning the appropriate use of Kerendia with the Account's patient care objectives. You will establish a comprehensive Strategic Account Business Plan aimed at creating long and short-term sales growth. You will penetrate physical access and market access barriers to achieve account objectives and create Kerendia Advocates and Clinical Champions throughout the Account by building strategic relationships with prescribers and administrators. Collaboration with cross-functional partners, including Market Access and Medical, Regional Sales Managers, and Sales Consultants, is essential. You will lead and coordinate pull-through at the local level. The span of coverage will be the Bay Area and Sacramento. The candidate must reside within the territory. Key Tasks and Responsibilities The primary responsibilities of the Regional Account Director are to: • Coordinate efforts of the cross-functional Bayer team to achieve short and long-term account objectives;, • Develop and execute a Strategic Business Plan and Account Map in alignment with cross-functional stakeholders (Medical, Market Access, Sales Leadership, etc.);, • Identify and access key stakeholders within the account who influence Kerendia Advocacy;, • Lead and coordinate field sales pull-through;, • Responsible for overall sales objectives in assigned key accounts, maximizing sales opportunity for Kerendia;, • Position Kerendia for appropriate patient types to key stakeholders throughout the Account;, • Collaborate effectively with internal stakeholders to achieve shared Account Objectives;, • Maintain a high level of communication with key customers;, • Manage and coordinate account strategy;, • Synthesize information quickly and ensure internal and external data are incorporated into Account Business Plans;, • Act in tandem with Market Access, Medical, and Sales organizations to strengthen relationships with key healthcare systems;, • Effectively influence critical healthcare accounts to understand the value of Bayer products;, • Proactively share insights with the business on account needs. Who You Are Bayer seeks an incumbent who possesses the following: Required Qualifications • Minimum 5 years of industry-relevant work experience with a strong network and relationships across healthcare systems and with Specialty HCP networks (i.e., Nephrologists, Endocrinologists, Cardiologists);, • Resourceful, strategic, and analytical thinker, and creative problem solver with a "See it, Own it, Solve it, Do it" approach;, • Ability to work cross-functionally and in a matrix environment;, • Business travel by air and car required up to 50%;, • Demonstrated experience in strategic planning and implementation;, • A clean and valid driver's license without any points;, • Strong understanding of market direction/business insight. Preferred Qualifications • 2 years of Account Management experience;, • Prior experience in pharmaceutical sales, market access, health outcomes, medical education, marketing, or other relevant disciplines. Employees can expect to be paid a salary between $124,320.00 - $186,480.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least 9-7-26.

If you are interested in joining an entrepreneurial team, focused on bringing life-saving therapies to market for critical unmet medical needs, consider applying for a role at CorMedix Therapeutics. The culture at CorMedix Therapeutics is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare. CorMedix Therapeutics's greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high-precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose. We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs. CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. Rezafungin is currently approved for the treatment of candidemia and invasive candidiasis in adults. The Key Account Manager (KAM) position is a hospital-based or integrated sites of care-based position focused on launching and selling innovative products in the assigned institutional accounts, including integrated delivery networks (IDNs) and alternate sites of care for infusion. The role includes educating clinicians on the clinical benefits of CorMedix Therapeutics products to facilitate and gain improved institutional formulary access while expanding appropriate product utilization, through protocol adoption, to exceed business and customer objectives with assigned hospitals and IDNs. The KAM also has accountability for pulling through contracts and facilitating account and clinician access opportunities to ensure achievement of CorMedix Therapeutic's business goals. KAMs are required to follow the hospitalized patient journey and call Long Term Acute Care hospitals and home infusion companies if determined necessary in their territories. Some of the products will require the KAM to call on infusion centers outside the hospital, open sites of care outside of a hospital for infusion as well as call on customers that refer into those infusion centers. This role will manage key accounts across the Sacramento, CA territory. • Increase product access and sales in the geographical area by navigating the institutional formulary approval process, as well as educating customers on appropriate use of CorMedix Therapeutic products., • Secure placement of CorMedix Therapeutic's products on appropriate account protocols and ensure products are in the EMR systems., • Develop relationships with local infusion sites, LTACH's and home infusion companies., • Develop territory and account-level plans to grow product utilization, formulary access, and expand the customer base., • Understand multiple interdependencies within an account, consider customer treatment goals and needs, and maximize account performance by aligning appropriate solutions, messaging, and stakeholders., • Establish and maintain professional relationships with customer opinion leaders and hospitals, including physicians, medical staff and pharmacies., • Plan, coordinate, and implement hospital-oriented education forums in accordance with company policies and business plans., • Partner with hospital treatment committees to include CorMedix Therapeutics products on appropriate disease state protocols., • Facilitate continuity of care for discharging patients via CorMedix Therapeutics product inclusion on discharge protocols/orders and alignment of approved CorMedix Therapeutics reimbursement resources., • Collaborate and communicate with Sales, Medical Affairs, National Accounts, Marketing, and Sales Administration on all needs, opportunities, Key Opinion Leader touch points, formulary changes and pull-through initiatives., • Proven track record of sales within a hospital environment of the assigned territory/accounts., • Recent acute care hospital or integrated sites of care sales experience in the assigned territory/accounts., • Ability to create alternate sites of care in assigned territory., • Understanding of how to sell in a buy and bill market., • Success planning and executing a new product or solution launch into a hospital/account setting., • Highly motivated, self-starter and results driven individual., • Must be able to work well independently and as a team member; under pressure, shifting priorities, and a changing landscape., • Strong project management skills to ensure timelines are met, as well as the ability to prioritize and multitask., • A passion for continuous professional development and learning., • Ability to work in a matrix environment and to value the importance of teamwork., • Ability to establish and build relationships and rapport with a diverse customer base., • Strong ability to learn and use technical product knowledge., • Willingness and ability to provide proof of childhood immunizations, a negative TB test and other requirements, as set by each hospital's credentialing protocol for access., • A Bachelor's degree is required., • Minimum of 7 years of related pharmaceutical sales, marketing and/or training experience., • Minimum of 3 years in an account selling role (selling in a hospital/account ecosystem, for all levels of the account.), • Valid driver's license and clean driving record., • The ability to travel as needed to sustain key relationships within the assigned territory and to attend both conferences and sales meetings., • Preferred Buy/Bill and Home Infusion experience., • Preferred hospital experience in Acute Care, Infectious Disease, and/or Hemodialysis. Exempt/Non Exempt: EXEMPT % Travel: Field-based position with frequent day-to-day travel expected EEO Statement: CorMedix Therapeutics is an equal opportunity employer. We do not discriminate against any individual on the basis of any status protected under applicable federal, state, or local law, including disability and protected veteran status.

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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 JOB SUMMARY: The Metrology Technician II leads calibration, troubleshooting, and maintenance activities for production, laboratory, and testing instruments. This role is responsible for ensuring the accurate execution of calibration schedules, resolving complex instrumentation issues, and supporting the development of junior staff. The Senior Metrology Technician works closely with the Metrology Supervisor to ensure all metrology activities comply with regulatory standards and company policies. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Calibration Execution and Oversight: Perform and lead calibrations on production, laboratory, and testing equipment in compliance with regulatory requirements (cGMP). Ensure that calibration schedules are adhered to, and results are properly documented. • Troubleshooting and Repairs: Lead troubleshooting efforts for complex instrumentation issues and coordinate with external vendors for major repairs as needed. Supervise in-house repairs of critical instruments to ensure timely and efficient resolution. • Documentation and Compliance: Maintain accurate and complete calibration and repair records in accordance with cGMP guidelines. Ensure all work is performed in compliance with internal procedures and regulatory requirements. • Process Improvement: Collaborate with the Metrology Supervisor to identify areas for process improvement within the metrology function, recommending and implementing changes to enhance efficiency and compliance. • Temperature Mapping: Oversee and perform temperature mapping activities across the facility, ensuring accurate data collection, analysis, and documentation in compliance with regulatory standards. • Collaboration and Support: Support the Validation Department by assisting with instrument qualifications, process qualifications, and other validation activities as needed. • Vendor Management Support: Assist the Metrology Supervisor in coordinating with external vendors for calibration services, repairs, and equipment purchasing. • Compliance and Leadership: Ensure all assigned tasks are completed with a focus on accuracy, timeliness, and adherence to regulatory requirements. Provide leadership and guidance to junior staff to ensure consistent compliance. • 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 to 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 accommodations 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. BENEFITS: Salary Range: 80-95K: Based on experience Performance-Based Incentive Benefits: Medical, Dental, and Vision coverage PTO, Sick Time and Floating Holidays To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. Nivagen Pharmaceuticals is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Nivagen will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. Nivagen 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 Position Summary Nivagen Pharmaceuticals is looking for a QA/QMS Senior Specialist - Deviations & Investigations to lead the deviation management process across sterile GMP manufacturing operations. This individual will be responsible for the timely initiation, investigation, root cause analysis, and closure of deviations in compliance with FDA/cGMP requirements. The role serves as the central point of contact for deviation lifecycle management and requires strong investigative skills, technical writing ability, and cross-functional coordination. Key Responsibilities • Own the deviation lifecycle from initiation through investigation, root cause analysis, corrective action identification, and closure within established timelines., • Serve as the primary point of contact for all deviation-related activities across Manufacturing, Quality Control, Engineering, and Validation departments., • Conduct thorough root cause analyses using structured methodologies including Ishikawa (6M), 5-Why, and fault tree analysis., • Author investigation narratives, initial quality assessments (IQAs), and final deviation reports in TrackWise., • Classify deviations by severity (Critical, Major, Minor) and assess impact on product quality, patient safety, validated state, and regulatory compliance., • Coordinate batch disposition activities in collaboration with QA batch release and QC laboratory teams., • Identify recurring deviation trends and escalate to the CAPA system when systematic issues are identified., • Track and report deviation KPIs including open aging, cycle time, recurrence rates, and root cause categories during management review., • Support internal audits and FDA/regulatory inspections by providing deviation records, trending data, and investigation summaries., • Ensure all deviations comply with ALCOA+ data integrity principles and 21 CFR Part 11 requirements for electronic records., • Serve as a trained backup for related QMS subsystems (CAPA and Change Control), providing cross-functional coverage during peak workload periods, absences, or as needed to ensure continuity of quality operations. Qualifications • Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Microbiology, Engineering, or a related field., • Minimum 7-10 years of experience in QA, conducting deviation investigations in sterile pharmaceutical manufacturing., • Demonstrated expertise in root cause analysis tools (Ishikawa, 5-Why, FMEA, fault tree analysis)., • Hands-on experience investigating sterile-specific deviations including media fill failures, environmental monitoring excursions, filter integrity test failures, particulate contamination, and aseptic processing breaches., • Proficiency with TrackWise, Veeva QMS, or equivalent electronic quality management systems., • Strong technical writing skills with the ability to author clear, concise, and FDA-defensible investigation reports., • Working knowledge of 21 CFR Parts 210, 211, and 212; ICH Q7 and Q10; and FDA guidance on investigating deviations., • Experience supporting FDA Pre-Approval Inspections (PAI) or routine GMP inspections is a plus., • Working familiarity with adjacent QMS processes (CAPA and Change Control) is strongly preferred; willingness to cross-train across these subsystems is required. What We Offer • Competitive salary and comprehensive benefits package., • Opportunity to build QMS infrastructure from the ground up at a growing pharmaceutical company., • Direct impact on FDA inspection readiness and commercial manufacturing success., • Collaborative work environment with a supportive quality leadership team., • Professional development and career growth opportunities. Benefits: • Pay range $80,000-$90,000 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 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: Technical Writer (Pharmaceutical GMP Environment) Job Description This Technical Writer role supports documentation activities in a regulated pharmaceutical manufacturing environment. You will author, review, and revise a wide range of GMP documents and quality system records while partnering closely with Manufacturing, Engineering, Validation, and Quality teams. The position is based in Sacramento, CA, operates primarily on a MondayFriday day shift schedule, and is offered as a 6month contract with potential for extension or conversion. The role is ideal for a self-starter who can quickly understand complex processes, identify documentation gaps, and independently produce clear, compliant, and technically accurate documentation with minimal supervision in a fast-paced, growing organization. Responsibilities • Author, edit, and maintain GMP documentation, including batch records, standard operating procedures (SOPs), deviations, investigations, corrective and preventive actions (CAPAs), change controls, qualification protocols, performance qualification (PQ) protocols and reports, validation documentation, and technical and summary reports., • Partner with Manufacturing, Engineering, Validation, and Quality teams to gather technical information and translate it into clear, concise, and compliant documentation., • Review existing documentation and workflows to identify gaps, inconsistencies, and opportunities for process and documentation improvement., • Ensure all documentation complies with FDA regulations, current Good Manufacturing Practices (cGMP), and internal quality and compliance standards., • Support the execution and documentation of quality system activities within electronic quality management systems., • Coordinate document revisions and updates based on process improvements, equipment changes, and evolving regulatory expectations., • Maintain document control, traceability, and compliance throughout the entire document lifecycle., • Participate in cross-functional projects and support business initiatives related to process improvements, validation activities, and organizational growth., • Quickly assess existing processes in the GMP environment, identify documentation gaps, and develop compliant documentation with minimal training or oversight., • Manage multiple documentation projects simultaneously while maintaining a high level of quality, accuracy, and regulatory compliance. Essential Skills • Bachelors degree in a scientific, engineering, or related discipline preferred., • 3+ years of technical writing experience in a regulated industry., • Experience authoring GMP documentation in a pharmaceutical, biotechnology, medical device, or other FDA-regulated environment., • Strong experience writing SOPs, batch records, deviations, investigations, CAPAs, change controls, and validation and qualification documentation., • Working knowledge of FDA regulations and current Good Manufacturing Practices (cGMP)., • Excellent written communication skills and demonstrated ability to produce clear, structured technical documentation., • Ability to independently gather information from subject matter experts, manage priorities, and execute projects with limited direction., • Strong attention to detail and ability to identify documentation gaps, inconsistencies, and compliance risks., • Ability to operate effectively in a fast-paced environment and manage multiple concurrent projects., • Target experience level of approximately 37 years in relevant technical writing and regulated environments. Additional Skills & Qualifications • Pharmaceutical manufacturing experience strongly preferred., • Experience supporting validation and qualification activities, including protocols and reports., • Familiarity with electronic quality management systems (QMS)., • Experience in company integration, process improvement, or documentation remediation projects is a plus., • Demonstrated ability to quickly understand complex manufacturing and validation processes in a GMP environment., • Organized, proactive, and comfortable working with cross-functional teams., • High level of independence, ownership, and execution in managing documentation responsibilities. Work Environment This role is based in Sacramento, CA, within a regulated pharmaceutical GMP manufacturing environment that emphasizes quality, compliance, and continuous improvement. You will work closely with Manufacturing, Engineering, Validation, and Quality teams and collaborate across functions on process improvement and validation initiatives. The schedule is primarily MondayFriday during the day shift, but flexibility is required to support occasional swing, graveyard, evening, or weekend work when manufacturing, validation, or quality activities demand it. The position is structured as a 6month contract with potential for extension or conversion, offering the opportunity to contribute to a growing organization with many exciting developments underway. The environment is fast-paced, detail-oriented, and highly regulated, with a strong focus on accurate documentation, adherence to FDA and cGMP requirements, and robust quality systems supported by electronic QMS tools. Job Type & Location This is a Contract position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $40.00 - $55.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Oct 9, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

Job DescriptionAutomation Controls Engineer Are you passionate about automation, controls, and keeping high-tech manufacturing systems running at peak performance? Join a growing pharmaceutical manufacturer where you'll play a key role in supporting automated production and packaging operations while driving reliability, efficiency, and continuous improvement. What You'll Do • Troubleshoot and support PLC, HMI, and SCADA systems across manufacturing and packaging operations, • Identify and resolve automation and process issues through root cause analysis, • Support automated packaging lines, filling systems, labeling equipment, robotics, vision systems, and motion control technologies, • Implement control system modifications while following GMP and change control requirements, • Partner with Manufacturing, Quality, Validation, and Engineering teams on system improvements, • Assist with FAT, SAT, IQ, OQ, and PQ validation activities, • Support serialization and MES systems to improve traceability and compliance, • Drive equipment reliability and continuous improvement initiatives, • Provide hands-on technical support for production equipment and automated systemsWhat We're Looking For, • Bachelor's degree in Engineering or a related technical field, • 3+ years of automation, controls, or manufacturing engineering experience, • Strong PLC programming and troubleshooting experience, • Experience with HMI and SCADA systems, • supporting automated manufacturing or packaging equipment, • Experience in regulated industries such as Pharmaceutical, Biotech, Medical Device, Food, or Chemical manufacturing, • Ability to troubleshoot complex production equipment and control systemsPreferred Experience, • Rockwell or Siemens PLC platforms, • Wonderware or other SCADA systems, • Packaging automation, robotics, vision systems, and motion control, • MES and serialization systems, • GMP environments and 21 CFR Part 11 compliance, • Pharmaceutical, biotech, or aseptic manufacturing experiencJob Type & Location This is a Permanent position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $135000.00 - $160000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Company offers Medical, dental & vision Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on Oct 16, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

Job DescriptionAre You Ready?CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical 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 approach is simple because our Purpose informs everything we do: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:- We act with integrity- We serve each other- We serve society- We work for our futureAt CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity.For us, operational readiness isn’t simply a goal—it’s a way of life. Tomorrow demands to be at the forefront of today. We get there through tireless effort, precision, efficiency, and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done. Key ResponsibilitiesCQV Execution & Safety- Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety- Deliver C&Q activities in alignment with project schedules- Track and report progress of CQV efforts Documentation & Compliance- Support the generation and review of C&Q procedures for client projects- Review and revise qualification-related documents, including SOPs, master plans, and execution plans- Assist with CQV review and qualification of equipment design Project Planning & Coordination- Support planning of commissioning spares and consumables- Allocate project resources for efficient execution- Coordinate support and logistics during CQV execution Testing & Vendor Management- Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities- Coordinate with project contractors and equipment vendors to execute required testing Qualifications and Experience- Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)- 2+ years of related experience in the Pharmaceutical/Life Sciences industry- Essential experience in a GMP (Good Manufacturing Practice) environment- Outstanding oral and written communication skills- Strong problem-solving abilities- Customer-focused mindset- Willingness and flexibility to travel throughout the U.S. and potentially internationally Critical CompetenciesInfluence Strategy- Evaluates and pursues opportunities based on organizational strategy- Identifies innovative solutions with strategic impact- Anticipates emerging customer and market needs Satisfy the Customer- Understands and anticipates client needs- Develops solutions that exceed expectations- Actively follows up to ensure satisfaction and loyalty Plan for Success- Aligns business strategies with actionable plans- Allocates resources effectively- Anticipates risks and builds contingency plans Pursue Execution- Prioritizes initiatives to ensure goal achievement- Holds self and team accountable- Proactively removes obstacles Tailor Communication- Communicates clearly, concisely, and professionally- Adjusts messaging to suit audience- Explains technical concepts across all levels Build Partnerships- Builds strong networks across teams and disciplines- Promotes collaboration and removes silos- Involves stakeholders in decision-making Influence Others- Builds support through sound reasoning- Gains buy-in from decision makers- Encourages innovation and better outcomes Develop Self and Others- Continuously develops relationship and leadership skills- Acts with integrity and models company values- Seeks out breakthrough opportunities#LI-MV1Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.We 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 Shift: Full Time | Monday to Friday | Rotating Overnight and Day shift Job Summary Working and training as an RLS Pharmacy Technician is a great way to learn an exciting new skill set within the field of pharmacy away from more traditional pharmacy challenges such as drive-throughs and insurance problems. As an RLS Pharmacy Technician, you will gain experience in areas such as aseptic processes, radiopharmaceuticals, general regulatory compliance and quality assurance. The Pharmacy Technician supports pharmacy operations by processing prepared products and handling, packaging and delivering radiopharmaceuticals. Key Accountabilities • Compound and dispense radiopharmaceuticals under the supervision of a Pharmacist, • Package radiopharmaceuticals for delivery for customers, • Perform quality control on compounded products, • Manage and maintain facility inventory, • Perform disinfection task in the cleanroom, and stocking of sterile supplies, • Maintain documentation for regulatory programs utilizing good documentation practices (gdp), • Process and/or dual verify prescription entries, • Perform leukocyte labeling procedures, • Duties as assigned by the Pharmacist Education and Experience: • Eligible to work in the United States., • High School Diploma or GED/local equivalent, • Ability to accommodate shift changes based on business needs, • PTCB certified or successful completion within 6 months of hire or current enrollment in an Accredited School of Pharmacy, • Applicable Pharmacy Technician State License, • Must be able to lift 50 pounds, • Proof of vaccination for Covid 19 to meet compliance obligations for Customer mandated on-site requirements, • Valid driver's license Key Capabilities: • Previous experience handling radiopharmaceuticals., • Previous experience processing prescriptions and/or preparing pharmaceutical, • Previous experience in sterile compounding., • Ability to communicate effectively and in a professional manner, • Ability to prioritize job duties., • Accept and adhere to high ethical values in decisions and actions

Job Description Overview PharMerica is hiring a full-time Pharmacy Technician in Sacramento, CA! Join our closed-door pharmacy team where you’ll work in a non-retail environment, dedicated to meeting the pharmaceutical needs of long-term care and senior living clients. If you’re passionate about delivering exceptional service and high-quality care, we want to hear from you. Apply today and become part of a team committed to making a difference! Schedule: Overnight 7 on 7 off Benefits and perks for you! • Medical, Dental, Vision insurance, • Health Savings & Flexible Spending Accounts (up to $5,000 for childcare), • Tuition discounts & reimbursement, • 401(k), • Company Paid Time Off*, • Shift Differential, • DailyPay, • Pet Insurance, • Employee wellness and discount programs *Benefits may vary by employment status Responsibilities How YOU will benefit: • Supportive team with room to work independently, • Ongoing training and career growth, • Advancement opportunities in a growing company, • Referral bonuses, • We cover Pharmacy Technician license fees (new hires & current staff eligible) As a Pharmacy Technician you will: • Fill prescription items and package medications for dispensing and delivery., • Accurately label products, including cautionary and auxiliary labels., • Prepare medications, including non-sterile compounding (liquids, powders, ointments, etc.)., • Enter patient and prescription data into the computer system to generate labels., • Participate in pharmacy inventory management, including checking stock and removing expired medications., • Handle returned medications per protocol (credit or destruction)., • Communicate professionally with internal and external customers., • Assist with onboarding and training new pharmacy staff., • Perform specialized tasks such as:, • Working in the Controlled Drugs (Narcotics) Room., • Operating automated machines to prepack medications., • Mixing IV medications and sanitizing IV room/equipment., • Servicing facility-based dispensing machines (e.g., RxNow)., • Perform other pharmacy support tasks as assigned. Qualifications Qualifications : Required: • High School diploma or equivalent., • Pharmacy Technician license as required by state, • Experience in a pharmacy setting and medical terminology., • Ability to operate a computer; recognize and identify medications., • Detail oriented; goal oriented, team player, and effective oral communication. Desired: • Long Term Care pharmacy experience. *Position will be posted for a minimum of 7 business day

Job Description More 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 commercial-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 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. Position Summary: The Specialist, EHS is responsible for supporting the development, implementation, and maintenance of environmental, occupational health, and workplace safety programs and policies to ensure compliance with local, state, and federal regulations and multiple sites. Location: Sacramento, CA (on-site). This role is primarily based at our "Sac02" commercial manufacturing facility on Metro Air Parkway (3–4 days per week), with regular time at our nearby "Sac01" site on Business Drive (1–2 days per week). Occasional travel to our Bay Area (Menlo Park) headquarters may be required (1–2 days per month). Physical Demands & Work Conditions • 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 meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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., • Must be comfortable regularly participating in video-based meetings.Key Responsibilities, • Ensure compliance with Cal/OSHA, EPA, DTSC, CDPH and other applicable regulatory standards, • Conduct safety audits, inspections, and risk assessments to identify and mitigate safety, health, and environmental risks. Coordinate implementation of identified corrective actions or improvements., • Lead safety committees and represent EHS interests in cross-functional meetings and project teams., • Develop, coordinate, and deliver EHS training programs for employees (HazCom, LOTO, PPE, emergency response, etc.), • Investigate near-misses, incidents, and injuries, and recommend and track corrective actions. Manage associated documentation and reporting requirements., • Develop, maintain and update EHS policies, procedures, and documentation, • Manage environmental programs including waste management, air emissions, and wastewater compliance, • Manage the proper handling, storage, disposal, documentation, and regulatory compliance of biohazardous and hazardous wastes, • Track and report safety metrics and environmental data, • Support emergency preparedness and response planning, • Collaborate with leadership to drive continuous improvement in safety performance, • Maintain EHS documentation, including SDSs, permits, and reporting., • Lead or support emergency response plans, drills, and preparedness activities.Qualifications, • Bachelor’s degree in Environmental Science, Occupational Health & Safety, Industrial Hygiene, or related field preferred., • 5 years of EHS experience in a GMP environment, preferably in a cell therapy, biotechnology or pharmaceutical manufacturing facility., • Working knowledge of Cal/OSHA, EPA, DTSC, CDPH and other relevant regulations, • Excellent leadership, communication, and interpersonal skills., • Excellent project and time management skills with the ability to manage multiple priorities in a fast-paced environment, • Strong analytical, attention to detail, and problem-solving skills, and ability to make sound decisions, • Certifications such as OSHA, HAZWOPER, CSP or CHMM are a plus., • This position requires on-site presence and typically involves regular office hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response., • Gowning will be required for cleanroom access. The anticipated annual salary range (listed above) 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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 More 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 commercial-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 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. Summary of Position: The Calibration Technician is responsible for inspecting, testing, calibrating, and maintaining measurement and test equipment to ensure accuracy and compliance with industry standards and company quality requirements. The Calibration Technician works closely with other departments to support the overall goals of the organization. Physical Demands & Work Conditions • 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 meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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., • Must be comfortable regularly participating in video-based meetings.Key Responsibilities:, • Perform calibration, adjustment, and repair of equipment used in GMP Production and Quality Control Lab testing (mechanical, electrical, electronic, and dimensional)., • Maintain calibration records in accordance with quality standards (ISO, ANSI, NIST, etc.)., • Utilize and maintain a Computerized Maintenance Management System (CMMS) to accurately track, plan, and document asset calibration, repairs, and inventory, ensuring data integrity for regulatory compliance., • Troubleshoot equipment performance issues and recommend corrective actions., • Ensure all Calibration Standards meet required tolerances and specifications., • Author and update calibration procedures., • Assist with internal and external audits., • Maintain a clean and organized calibration lab., • Coordinate with production and engineering teams to minimize downtime.Qualifications:, • Associate degree or technical certification in Electronics, Engineering Technology, or related field (or equivalent experience)., • 4 years of calibration experience in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical manufacturing facility., • Strong knowledge of measurement principles and standards (ISO 9001, ISO/IEC 17025 preferred)., • Experience with Calibration Standards such as multimeters, temperature sensors pressure gauges, torque tools, tachometers, calipers, and other precision instruments., • Experience with GMP regulatory standards, and documenting work per GDP requirements., • Ability to read technical drawings and schematics., • Strong attention to detail, documentation, communication, and interpersonal skills., • Proficiency in Microsoft Office, maintenance management, and calibration management software., • Familiarity with NIST traceability requirements., • Strong problem-solving and analytical skills., • Ability to work independently and as part of a team., • The position requires on-site presence and typically involves regular hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response., • Gowning for cleanroom access., • Ability to lift up to 40 lbs., • Manual dexterity for handling small components. The anticipated annual salary range (listed above) 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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 More 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 commercial-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 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 Assurance, is responsible for overseeing day-to-day activities of the QA team directly supporting manufacturing and quality control operations. This role provides direct support to the site to ensure compliance with regulatory standards, internal procedures, and quality expectations. The QA Supervisor provides leadership and guidance to the QA team, driving a culture of continuous improvement, compliance, and operational excellence. The department is responsible for performing real-time record review of production records, equipment logbooks, and QC documentation. Additionally, this department collaborates across the site to provide real time manufacturing support, supporting issue resolution and documentation. Swing Shift Schedule: • Monday - Friday, 2:00pm to 10:30pm Physical Demands & Work Conditions • 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 meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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., • Must be comfortable regularly participating in video-based meetings.Key Responsibilities Leadership and Team Management: • Supervise, mentor, and develop a team of QA technicians assigned to manufacturing and QC operations., • Schedule and prioritize daily QA activities to ensure timely support for production and lab functions., • Provide ongoing training, performance evaluations, and career development support for team members., • Serve as QA representative in cross-functional meetings related to operations and quality systems, promoting a culture of compliance and continuous improvement., • Provide technical guidance and mentorship to ensure high quality and compliant practices. Operational Support: • Oversee on-the-floor QA support for manufacturing and QC activities including batch record review, in-process checks, line clearance, and deviation response., • Ensure timely review and approval of manufacturing and QC documentation (e.g., batch records, logbooks, equipment use records, test data)., • Support real-time issue resolution during production and testing activities, escalating concerns as needed., • Monitor compliance with Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and internal SOPs., • Assist in the preparation and review of master batch records, standard operating procedures (SOPs), and other relevant documentation. Quality Systems & Compliance: • Supervisors are expected to supervise Quality System performance for themselves and their team., • Ensure effective implementation and adherence to quality systems including deviation management, CAPAs, change control, and investigations., • Review and approve deviations, investigations, and change controls related to manufacturing and QC., • Participate in internal audits, regulatory inspections, and third-party audits as required., • Support trending of quality data and contribute to continuous improvement initiatives., • Collaborate with cross-functional teams (QC, Manufacturing, MSAT, etc.) to drive resolution of quality and technical issues. Record Management Readiness: • Monitor record management conditions and practices to ensure consistent compliance with cGMP and FDA/EMA regulations., • Manage documentation, equipment logs, and records to support readiness for internal and external inspections., • Lead preparation activities for audits and regulatory inspections, including document reviews and mock audits. Continuous Improvement, Collaboration, and Communication: • Identify opportunities to enhance operations, workflow efficiency, and compliance practices., • Participate in the revision and development of SOPs and policies., • Liaise with Manufacturing, QC, Validation, Engineering, and other departments to ensure QA oversight and alignment., • Communicate quality expectations, regulatory changes, and quality system updates to the team and relevant stakeholders., • Support implementation of new procedures, processes, and equipment from a QA perspective., • Perform other duties as requested by supervisor/manager to support Quality., • Stay current with industry regulations, standards, and best practices related to quality assurance., • Minimum Qualifications, • Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related scientific discipline, • Minimum of 5 years of experience in Quality Assurance within a regulated pharmaceutical, biotechnology, or medical device environment., • Minimum of 1-2 years in a leadership or supervisory role is preferred., • Strong knowledge of cGMP, FDA, and ICH guidelines., • Strong analytical, problem-solving, and decision-making skills., • Excellent written and verbal communication., • Detail-oriented with strong organizational skills., • Ability to manage multiple priorities and work in a fast-paced environment. Swing shift is eligible for a shift differential pay of +5%. The anticipated annual salary range (listed above) 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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 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 commercial-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 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 Operations Supervisor, Logistics & Cold Chain Operations leads the teams responsible for the secure, compliant, and on-time movement of donor cells and cell therapy drug products between Orca Bio's Sacramento manufacturing sites and transplant centers nationwide. This is a hands-on people- leadership role that owns end-to-end operational readiness across two functions: the Logistics Specialist team, which coordinates live courier runs, disruption response, chain-of-custody, and vein-to- vein (V2V) performance; and the cold chain / packaging operations hourly team, which prepares, charges, and qualifies shippers and executes GMP packing and handover. This is a hands-on leadership role. Reporting to the Logistics Program Manager, the Operations Supervisor owns full operational accountability for their team — staffing and qualification currency, KPI performance, real-time disruption response, and continuous improvement — and is expected to be present and available for their team through the parts of the day that matter most. Each Operations Supervisor partners closely with their day-side/night-side counterpart to ensure consistent leadership and a clean handoff between teams. The ideal candidate is a calm, decisive operator who builds strong teams, thrives in a fast-paced regulated environment, and can move fluidly between strategic planning and real-time problem-solving when a shipment is at risk.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.Schedule & Team Presence:This role is staffed as two positions one day and one night Supervisor. These are on-site salaried leadership roles. Rather than working a set schedule, each Operations Supervisor is expected to be present for their team when it matters most — during active courier runs, shift handoffs, coverage gaps, onboarding, and non-routine events — and flex their hours to align with their team's rhythm and the demands of the operation. The two Operations Supervisors coordinate to maintain consistent leadership coverage and a clean handoff between the day and night teams.Essential Duties & Key Responsibilities:Team Leadership & Shift Coverage • Lead, develop, and retain a cross-trained logistics and cold chain team, setting clear expectations, standards, and accountability. • Be present and available for the team during active runs, handoffs, and coverage crunches, adjusting hours to when leadership presence matters most., • Balance workload across sites (SAC-01 / SAC-02) based on batch volume and operational demand., • Run structured handoffs with your counterpart Operations Supervisor so active runs, at-risk shipments, and open issues transfer cleanly between the day and night teams. Logistics Operations & Vein-to-Vein Performance • Own vein-to-vein (V2V) performance for the network; monitor KPIs, identify trends, and drive corrective and preventive action when targets are missed., • Oversee real-time coordination of active courier runs, ensuring proactive tracking of flights, weather, and disruptions., • Direct disruption and incident response: flight and hotel rebooking, itinerary and TSA letter re- issuance, negotiating with third parties to ensure minimal delays., • Partner with manufacturing, case management, and clinical scheduling to triage the impact of delays on batch and delivery timelines. Cold Chain & Packaging Operations Oversight • Ensure cold chain readiness across the operation, including Credo and dry-shipper charging, preparation, qualification, and recirculation., • Oversee GMP packing, asset checkout and batch assignment in TrakSYS, final handover, chain- of-custody execution, and shipping-condition confirmation., • Maintain adequate qualified shipper inventory and asset availability to meet forecasted batch demand., • Ensure temperature monitoring, data upload, and excursion response are handled promptly and documented correctly. Chain of Custody, Compliance & Quality • Ensure chain-of-custody (CoC) documentation, temperature data, and return-of-materials tracking are complete, accurate, and compliant., • Maintain compliance with GMP/cGMP, IATA, DOT, and applicable transport and cold chain regulations.• Partner with Quality on deviations, CAPAs, and audit readiness; ensure SOPs are current and consistently followed., • Update delivery times in OrcaLink and ensure V2V capture for KPI reporting. Courier / Orca Porter Program & Vendor Management, • Partner with the Logistics Program Manager in owning the Orca Porter courier program, including courier scheduling, flight and travel logistics, and performance tracking and optimization., • Partner in leading third-party (3PL) courier implementation, vendor relationships, and issue resolution., • Review and approve courier invoices, and manage cost and performance across airlines, travel providers, and 3PLs., • Oversee commercial site feasibility assessments and dry-run support for new and existing treatment centers. Continuous Improvement & Scale • Continuously evaluate and improve logistics and cold chain workflows to support operational scalability and commercial growth., • Contribute to and maintain training programs, SOPs, and qualification frameworks., • Support capacity planning, tooling, and process changes that increase reliability and throughput as volume grows. Cross-Functional Partnership • Partners closely with Manufacturing, Quality, Clinical Scheduling, Commercial Case Management, and external donor and recipient organizations., • Represents Logistics & Cold Chain in operational planning, readiness reviews, and cross- functional projectsMinimum Experience, Education, Certifications, Licenses:• Bachelor's degree and 5–7 years of relevant logistics or supply chain experience required. B.S. in biology, life sciences, supply chain, or logistics preferred., • 2+ years of direct people-management experience, including hiring, scheduling, and performance management., • Proven success leading logistics and/or cold chain operations, preferably in a regulated environment. Working knowledge of chain-of-custody requirements and cold chain handling of biological or pharmaceutical materials., • Proficiency in logistics tracking systems or software requiredPreferred Experience:• Cell/gene therapy, biologics, or other time- and temperature-sensitive supply chain leadership., • Managing a 24/7 or multi-shift operation with on-call coverage., • Cold chain qualification and packaging operations (e.g., Credo, dry shippers, temperature monitoring, TrakSYS or equivalent MES/asset systems)., • Knowledge of IATA, DOT, and GMP/cGMP compliance; experience partnering with Quality on deviations and CAPAs., • Courier / 3PL program management., • Continuous improvement (Kaizen) , SOP development, and scaling operations in a startup or high-growth environmentLeadership & Personal Qualities:• Builds, develops, and retains strong teams; leads by example regardless of title., • Highly detail-oriented, with an unwavering commitment to quality, safety, and compliance., • Decisive and composed under pressure; adapts quickly to change and keeps the team steadyduring disruptions., • Takes ownership and drives forward without waiting for instruction., • Naturally curious, eager to learn, and energized by solving problems., • Communicates clearly and professionally with internal and external stakeholders., • Comfortable juggling multiple priorities in a fast-paced, startup environment., • Embraces a positive attitude, a collaborative spirit, and a good sense of humorReporting Structure & Authority:Supervisory Responsibilities, • Directly manage the Logistics Specialists on your team, and oversee the cold chain/packaging operations hourly team., • Own hiring, onboarding, scheduling, timekeeping approvals, performance management, coaching, and career development for your team across both functions., • Partner with your dayside/night-side counterpart Operations Supervisor to align standards, share status, and execute a clean, documented handoff so nothing falls between teams., • Maintain coverage and escalation paths for your team that protect V2V timelines without creating burnout or single points of failure. -Ensure every team member maintains current training and qualification (including courier run currency and packaging-operations certifications) and that records are audit-ready. • Be a visible, available escalation point for your team on non-routine transport and cold chain issues.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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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 This position is responsible for supervising Nivagen label control and packaging area. Works in SAP system and Quality system to perform inspection testing of incoming labelling and packaging components. Supervising the packaging team to provide oversight of Packaging and making sure that AQL's support finished product release. The position is a liaison with the warehouse, customer service and manufacturing for incoming goods both finished product and incoming components. The position is responsible for implementing Nivagen inspection and testing quality standards for labelling and incoming packaging components, while leading the packaging QA team to meet Nivagen timelines. ESSENTIAL DUTIES AND RESPONSIBILITIES • Manage the Label Control Program ensuring that finished product is appropriately labeled to the correct versions and timelines. This includes management of specifications, inspections, and release of labelling in SAP., • Manage the Packaging Component Specification program by obtaining documentation for components that have product contact from project managers, engineers, or purchasing., • Prepare or review change controls to introduce product/components into Nivagen Quality System., • Develop quality inspection criteria for finished products to include label review, temperature requirements, and destructive testing for quality attributes, if applicable., • Create documentation for Quality inspection of each packaging component against supplier drawings, supporting documentation and physical testing., • Work with Engineer and Operations for component acceptability testing on the line in conjunction of writing component specifications for approval., • Sample and inspect incoming drug products and/or components against quality standards. Record and review documentation for accuracy and completeness., • Maintain the initial and final documentation in the electronic management system., • Disposition of product/component after quality review of inspection criteria, • Set up metadata in SAP of new drug products and establish workflows for inspection criteria in the documentation quality system., • Interact with Purchasing and Supplier for investigations into non conformances, writing deviations, and SCAR reports., • Track labelling and packaging components supplier performance and assist in quality agreements., • Maintain all working areas in a clean and orderly state. Assure products are stored, segregated and clearly labeled., • Ensures timely release of products in compliance with established standards., • Assist in the QA release process, ensuring products meet established quality standards before release for production., • Demonstrate proactive leadership through GMP regular audits, monitoring, and enhancing the efficiency and effectiveness of QA release procedures., • Review/approve documents as a Quality Subject Matter Expert (SME)., • Develop and uphold Standard Operating Procedures (SOP) and protocols, ensuring they align with quality practices and meet regulatory requirements., • Review batch records for accuracy and completeness for product disposition. Ensure that corrections are made in a timely manner., • Apply a working knowledge of statistical based sampling plans., • Write reports and provide information needed to investigate, document and close deviation. QUALIFICATIONS To perform this job, the individual must have FDA 21Part210/211 knowledge. Quality inspection experience in component or final product inspection is required. Experience in a pharmaceutical environment is required (3 years minimum) Self-motivated and proactive in preparing documentation and testing products. EDUCATION AND EXPERIENCE Knowledge of quality assurance in the drug industry with emphasis on contract manufacturing requirements. Must have experience in inspection techniques, knowledge of batch records, certificates of compliance and assurance. Must pay attention to detail and perform inspections according to defined specification. Understand computer entry of meta data for setting up workflows in SAP. Familiar with Track wise System RESPONSIBILITY FOR FUNDS, PROPERTY and EQUIPMENT None. COMMUNICATION SKILLS Ability to read and understand simple instructions, short correspondence, notes, letters and memos; Ability to write simple correspondence. Must be able to verbally and write comprehensive communications. MATHEMATICAL SKILLS 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. CRITICAL THINKING SKILLS Ability to utilize common sense understanding in order to carry out written, oral or diagrammed instructions. Ability to deal with problems involving several known variables in situations of a routine nature. SUPERVISION RECEIVED Under general supervision where standard practice enables the employee to proceed alone on routine work, referring all questionable cases to manager. Requirements: • Valid driver's license and acceptable driving record, • Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents), • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Able to successfully complete a drug and background check, • Able and willing to walk, stoop, stand, bend, and lift throughout each shift, with or without accommodation Benefits: • Pay range $75,000- $90,000, • 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 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 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 Apply Here: https://secure.onehcm.com/ta/VITREO.jobs?ShowJob=755153921&TrackId=ZipRecruiter Come and join our team! We are a local growing private medical practice specializing in the diagnosis and treatment of patients with diseases of the retina and vitreous. We are looking for individuals who would like to establish a career in healthcare working with nationally recognized physicians. We provide on the job training giving you the ability to grow and advance your skills along with gaining innovative knowledge. Established in 1977, we have locations all over Northern California including Sacramento, Grass Valley, Roseville, Stockton, Modesto, Merced, Fairfield, Elk Grove, Folsom, Yuba City and Chico. Our physicians are nationally known, and we continue to be on the leading edge of retina care by utilizing the latest equipment and both participating in and designing new clinical trials to advance the state of care for retinal diseases. Join 250+ other team members working for our nationally recognized retina specialty practice in a fast paced, high volume medical office. We are currently participating in several trials at two of our office locations and have a growing clinical research department. The research assistant is primarily responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. We seek a full-time clinical research assistant to support our clinical research department. Although you must be able to work independently, you will be working directly with physicians, patients, research coordinators, clinical and business office staff and with pharmaceutical sponsor representatives to correctly and efficiently execute clinical research protocols. Collaboration and being a team player are essential to the success of this role. Responsibilities • Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines., • Prepare visit-specific documentation and charts for Clinical Research Coordinator, • Observe Coordinator in patient care and management, • Assist Coordinator in monitoring subject flow and assist in subject care and management, • Observe, assist, collect and record all necessary data for follow up, • Transcribe subject study information from source documents to the Electronic Case Report Forms, • Administer all mandatory questionnaires to study subjects, • Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol, • Promptly request all necessary medical records for Serious Adverse Event Reporting, • Process and ship laboratory biological samples for analysis, • Perform intraocular pressure checks after injections, • Perform trial frame refraction and visual acuity testing, • Perform other duties as assigned

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 Inc., 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: • 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. Required Skills/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., • 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 Compliance Wire, Track Wise, SAP, LIMS, or similar eQMS platforms preferred., • Proficiency in Microsoft Office applications. Education and 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). 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: • May require working in shifts, including nights or weekends, depending on production schedules, • Adherence to safety protocols, including the use of personal protective equipment (PPE) and compliance with GMP standards, is mandatory, • This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment, • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $80,000-$90,000 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 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 Intellectual Property Patent Litigation Associate Attorney (Life Sciences) Direct Counsel is seeking an Intellectual Property Patent Litigation Associate Attorney (Life Sciences) to join a prestigious Am Law firm in Austin, Boston, Charlotte, Chicago, Houston, Irvine (Orange County), Los Angeles, Miami, New York City, Portland, Sacramento, San Francisco, Santa Monica, Seattle, Silicon Valley (Menlo Park), or Washington, D.C. This is an exceptional opportunity for an attorney with 2-7 years of patent litigation experience to join a nationally recognized Intellectual Property practice focused on life sciences. The team represents leading biotechnology, pharmaceutical, and life sciences companies in complex, high-stakes patent disputes from pre-trial through appeal. Responsibilities Represent clients in life sciences patent litigation in federal courts and other forums. Handle all phases of patent litigation, including pleadings, fact and expert discovery, motion practice, trial preparation, and appeals. Draft substantive motions, briefs, memoranda, and other litigation filings. Conduct legal and technical research involving complex life sciences technologies. Work closely with scientific experts, inventors, and corporate clients to develop litigation strategies. Analyze patent portfolios and scientific data in support of litigation matters. Collaborate with multidisciplinary legal teams on sophisticated intellectual property disputes. Manage multiple complex matters while providing exceptional client service. Qualifications J.D. from an ABA-accredited law school. Active membership in the state bar of the office where the attorney will be located. 2-7 years of intellectual property litigation experience, including at least 2 years of life sciences patent litigationexperience. Experience drafting briefs and participating in all phases of fact and expert discovery. Technical background in Biology, Chemistry, Pharmacology, or a related life sciences discipline is strongly preferred. Excellent legal research, analytical, drafting, and advocacy skills. Outstanding written, verbal, and interpersonal communication skills. Strong academic credentials with exceptional attention to detail. Ability to manage multiple complex matters while working collaboratively in a fast-paced environment. Compensation & Benefits Salary: $235,000-$435,000, commensurate with experience and qualifications. Comprehensive benefits package, including: Medical, dental, vision, and life insurance Mental health and wellness programs Child, family, elder, and pet care benefits Short- and long-term disability coverage Industry-leading parental leave Health Savings Account (HSA) and Flexible Spending Account (FSA) options 401(k) retirement plan Flexible Time Off (FTO) and paid holidays Annual discretionary performance bonus eligibility

Job Description More 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 commercial-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 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 Senior Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, operating and maintaining all utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization. Facility Operations & Maintenance: Oversee the day-to-day operations and maintenance of the facility, ensuring all systems are functioning properly (HVAC, chilled water, heating hot water, clean dry air, electrical distribution, emergency generator, uninterruptible power, RODI water, domestic water systems, etc) Manage service provider relationships (cleaning, pest control, security, maintenance and technical support services, etc.), ensuring delivery of quality services and compliance with service agreements. Develop, implement and manage preventive maintenance and calibration programs to ensure the facility is GMP compliant. Collaborate with Facilities and Production Planning to schedule and coordinate repairs and maintenance activities for building systems and equipment. Ensure accurate record-keeping for facility operations, and equipment maintenance, including Computerize Maintenance Management System (CMMS) and logbooks. Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures Track and report on system/equipment downtime, failure trends and develop corrective actions to prevent recurrence Coordination and execution of onsite and preventative and corrective maintenance, calibration and certification activities completed by service providers Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS Health, Safety & Compliance: Ensure the facility complies with all relevant safety, environmental, and regulatory requirements (e.g., OSHA, GMP, FDA, local building codes). Participate in regular inspections to identify and mitigate risks related to safety, health, and environmental impacts. Budget Management: • Support development and management of the facility’s operational and maintenance budget, controlling costs related to maintenance, repairs and outside services.Project Management: Plan and coordinate facility-related projects such as improvements or expansions. Manage projects related to the installation of new equipment. Work with other departments and external contractors and vendors to ensure successful project execution. Education Requirement: • Bachelor’s degree in Facility Management, Engineering, or related field preferred, or equivalent job experience. Experience Requirement:, • 7-10 years of experience in facility operations and management in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical industry.Skill Requirement: Strong knowledge of building systems operations (HVAC, RODI, compressed air, domestic water, electrical), maintenance and calibration programs, GMP regulatory standards, and safety requirements in the biopharmaceutical/cell therapy industry. Excellent leadership, communication, and interpersonal skills. Experience/proficiency with maintenance management software and systems. Excellent project and time management skills with the ability to oversee multiple tasks at once. Budgeting experience. Problem-solving and troubleshooting, and ability to make sound decisions. Working Conditions: • The position requires on-site presence and regular work hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response. 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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 More 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 commercial-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 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. Position Summary: The Manufacturing Systems & Master Data Administrator serves as the business owner and super user for the company's Manufacturing Execution System (MES) and related manufacturing and supply chain applications. This role is responsible for governing manufacturing master data, driving system improvements, optimizing business processes, and ensuring system capabilities effectively support GMP manufacturing, inventory management, procurement, quality, planning, and commercial operations. The Administrator owns the creation and maintenance of manufacturing and supply chain master data, including material masters, inventory masters, Bills of Materials (BOMs), product specifications, packaging configurations, vendor master records, release testing requirements, and manufacturing data. In addition, this role leads continuous improvement initiatives for ERP/MES functionality, serves as the primary business liaison to Information Technology, Finance and Software vendors, and ensures business systems evolve to meet operational and regulatory needs. No direct reports. Essential Duties and Responsibilities • Serve as the business owner / user for ERP, MES, and related manufacturing systems ensuring systems align with operational requirements and GMP compliance., • Develop and maintain manufacturing system standards, procedures, and work instructions., • Partner with IT and software vendors to resolve system issues and implement improvements., • Lead User Acceptance Testing (UAT), business validation activities, and deployment of system upgrades., • Develop business requirements and functional specifications for new capabilities and enhancements., • Own all material master records within Material Management (ERP/MES) systems., • Create and maintain raw materials, consumables, packaging, labels, and finished goods., • Create and maintain inventory attributes, storage conditions, shelf life, and lot control parameters., • Create and maintain Bills of Materials (BOMs)., • Maintain manufacturing recipes and packaging configurations (where applicable)., • Maintain material specifications and approved supplier information., • Link release testing requirements and quality specifications to materials., • Create and maintain vendor master records in partnership with Procurement., • Manage units of measure, conversion factors, and planning parameters., • Support engineering changes, change controls, and product introductions., • Ensure data integrity and GMP compliance., • Coordinate master data changes and system changes across Procurement, Manufacturing, Quality, MSAT, and Supply Chain.Required Qualifications:, • Bachelor's degree in Engineering, Supply Chain, Information Systems, Business, Life Sciences, Computer Science, or a related discipline., • 3+ years of experience in manufacturing systems, supply chain systems, ERP/MES administration, manufacturing operations, or master data management., • Experience in pharmaceutical, biotechnology, cell therapy, gene therapy, or other GMP-regulated manufacturing environments., • Experience serving as a business owner or super user for ERP and/or MES systems., • Experience implementing or enhancing ERP/MES solutions in a manufacturing environment, • Excellent interpersonal, leadership, and communication skills., • Experience with autologous or allogeneic cell therapy supply chains, preferred., • Certification in Production and Inventory Management or Logistics, such as APICS are a plus 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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 Overview PharMerica is hiring a full-time Pharmacist in Sacramento, CA! Join our closed-door pharmacy team where you’ll work in a non-retail environment, dedicated to meeting the pharmaceutical needs of long-term care and senior living clients. If you’re passionate about delivering exceptional service and high-quality care, we want to hear from you. Apply today and become part of a team committed to making a difference! Schedule: Overnight 7 on 7 off Benefits and perks for you! • Medical, Dental, Vision insurance, • Health Savings & Flexible Spending Accounts (up to $5,000 for childcare), • Tuition discounts & reimbursement, • 401(k), • Company Paid Time Off, • Shift Differential, • DailyPay, • Pet Insurance, • Employee wellness and discount programs *Benefits may vary by employment status Responsibilities How YOU will benefit: • Supportive team with room to work independently, • Ongoing training and career growth, • Advancement opportunities in a growing company, • Referral bonuses As a Pharmacist you will: • Evaluate physician medication orders for drug appropriateness, correct dosage, potential drug interactions, and proper route of administration., • Provide clinical recommendations to physicians and healthcare staff regarding medication therapy changes and optimizations., • Maintain up-to-date patient/resident profiles, including medical history, lab results, and current medications (prescription, OTC, and home remedies)., • Ensure laboratory tests required for monitoring high-risk medications are appropriately ordered, reviewed, and communicated to the healthcare team., • Collaborate with physicians, nurses, and other healthcare professionals to provide clinical and technical support., • Document all communications and clinical interventions in the patient’s medical record, including interactions with families and caregivers., • Implement and enforce policies and procedures for the safe handling, dispensing, and clinical oversight/management of medications., • Ensure compliance with all state and federal regulatory requirements related to pharmacy practice and medication management., • Report medication-related errors and adverse drug events to the Pharmacy Manager as required., • Educate and support clinical team and healthcare agency staff on safe and effective medication handling procedures., • Perform other pharmacy-related tasks and responsibilities as assigned. Qualifications Qualifications Required: • Bachelor’s Degree in Pharmacy, Pharm D preferred, • One year experience in long term care desired, • License/Certification(s): current and valid pharmacist license in the state of practice, • Knowledge of drug therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA)., • Proficiency in electronic medical records and pharmacy information systems, • Strong clinical judgement, and effective written and verbal communication *Position will be posted for a minimum of 7 business day

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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Lab Technician As a Lab Technician at Nivagen you will be responsible for supporting the laboratory operations by conducting routine tests, preparing samples, maintaining laboratory equipment, and ensuring compliance with Good Laboratory Practices (GLP) and regulatory standards. The technician will work closely with chemists, scientists, and other technical staff to ensure the smooth and accurate testing of pharmaceutical products. Responsibilities: • Analyze assigned samples using various instruments, primarily HPLC., • Maintain laboratory logbooks and usage/consumption logs., • Clean and maintain all laboratory areas., • Adhere to and comply with cGLP and cGMP standards., • Operate laboratory instruments as per SOPs., • Management of chemicals, reagents, standards, HPLC columns, etc., • Contact service engineer when necessary to calibrate laboratory instruments., • Handle the disposal of chemicals and samples, • Prepare and review SOPs., • Prepare and review COAs., • Prepare other documents related to analytical activities, including protocols, templates, reports, specifications, and STPs., • Develop analytical methods under the guidance of supervisor., • Perform any additional tasks as assigned by the Chief Scientific Officer (CSO). Qualifications: Education/Experience: • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Knowledge, Skills, and Abilities: • Experience with standard laboratory equipment, such as pipettes, graduated cylinders, and balances., • Experience with laboratory techniques related to measuring, weighing, and handling of samples., • Experience with HPLC is highly desired., • Familiarity with handling chemicals, especially the safety precautions and documents (SDS) related to such., • Proficiency in Microsoft Office., • Knowledge of chemistry and pharmaceuticals, as well as the terms and concepts related to such., • Knowledge, familiarity, or experience with cGMP is desired. Requirements: • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range based on experience, • 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 DescriptionControls Engineer (Facilities & Utilities) Ready to work on the systems that keep a pharmaceutical facility running? We're looking for an Automation Controls Engineer to support critical facility, utility, and environmental control systems within a highly regulated manufacturing environment. This is a hands-on role supporting everything from cleanroom HVAC and Building Management Systems (BMS) to purified water, clean steam, and environmental monitoring systems. What You'll Do • Support and troubleshoot BMS, EMS, PLC, HMI, and SCADA systems, • Ensure reliable operation of cleanroom HVAC, pressure, temperature, and humidity control systems, • Maintain and optimize critical utility systems including purified water, WFI, clean steam, compressed air, process gases, and chilled water, • Respond to alarms, investigate system issues, and drive root cause analysis, • Support control system upgrades, change controls, and validation activities, • Configure alarms, trends, graphics, databases, and monitoring systems, • Troubleshoot field instrumentation, sensors, valves, VFDs, networks, and control loops, • Partner with Facilities, Maintenance, Quality, Validation, and Engineering teams on system improvements, • Participate in commissioning, qualification, and reliability improvement projects, • Help ensure systems remain compliant, validated, and inspection-readyWhat We're Looking For, • Bachelor's degree in Engineering or a related technical field, • 5+ years of experience in controls, automation, facilities, utilities, or building systems, • Hands-on experience with Building Management Systems (BMS) and/or Environmental Monitoring Systems (EMS), • Strong PLC, HMI, and SCADA troubleshooting experience, • Experience supporting HVAC controls, cleanrooms, or critical utility systems, • Ability to read P&IDs, electrical drawings, and control schematics, • Comfortable working in manufacturing facilities, utility areas, and cleanroom environmentsPreferred Experience, • Pharmaceutical, biotech, medical device, semiconductor, food, or other regulated manufacturing environments, • Purified Water (PW), Water for Injection (WFI), and Clean Steam systems, • GMP and FDA-regulated environments, • Commissioning, qualification, and validation activities, • OT cybersecurity and industrial networking, • Environmental Monitoring Systems and cleanroom operations, • Sterile manufacturing or aseptic processing environmentsJob Type & Location This is a Permanent position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $135000.00 - $160000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Company offers medical, dental and vision Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on Oct 14, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

Job Description Pharmaceutical Manufacturing & Research Co. (Sacramento, CA) seeks Research Chemist to conduct method development, validation, stability & release testing of drug substances & drug products using GC, GC-MS, LC-MS , HPLC or ICP-MS. Support OOS investigations, CAPA and ANDA/NDA Submissions in alignment with cGMP, GLP & FDA guidelines. Prepare technical reports & maintain accurate lab records. Salary: $74,859.00 – $75,000.00/year. Send resumes to: Nivagen Pharmaceutical LLC at Hrusa@nivagen.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, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: QA Specialist– Visual Inspection and Packaging 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: • Provide real-time QA oversight during visual inspection, secondary and tertiary packaging, and final dispatch operations for sterile injectable products., • Perform real-time review and verification of batch manufacturing and packaging records during execution., • Perform and document the AQL visual inspections in accordance with approved procedures and sampling requirements., • Perform artwork verification and review/approval of labelling and packaging components, including specimen labels and printing details., • Verify issuance, accountability, reconciliation, and proper use of labels, cartons and other packaging materials required for batch packaging as per packaging record., • Perform packaging material reconciliation and reject verification., • Verify line clearance and area readiness prior to applicable visual inspection and packaging activities., • Identify, document, and support investigation (as applicable), documentation, labeling, packaging, and material discrepancies., • Perform QA verification of rejected units and packaging components, as applicable., • Coordinate and verify the collection/removal of retention samples, stability samples, finished product samples, and other required samples., • Provide QA oversight during final dispatch activities, including verification of applicable product, labeling, packaging, shipment, and dispatch documentation prior to release for shipment., • Verify that applicable batch, shipment, and dispatch records are complete, accurate, and appropriately reconciled prior to final dispatch., • Ensure product and associated materials are appropriately identified, accounted for, and released in accordance with approved procedures., • Review executed documentation for completeness, accuracy, traceability, and compliance with GDP and cGMP requirements., • Work closely with Manufacturing, Packaging, QC, Warehouse, Supply Chain, and other cross-functional teams to ensure timely resolution of QA-related issues., • Support batch review, discrepancy investigations, and other QA activities associated with visual inspection, packaging, and dispatch operations., • Ensure compliance with 21 CFR 211.192 (Checking Operations) and ALCOA+ data integrity principles in all batch record review activities., • Ensure all activities are performed in accordance with approved SOPs, batch records, specifications, and applicable regulatory requirements. Qualifications & Experience • Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or a related field preferred., • Hands-on experience in In-Process QA, visual inspection, packaging, batch record review, and/or final dispatch activities within a pharmaceutical manufacturing environment., • Experience in pharmaceuticals/Biopharmaceuticals sterile injectable manufacturing is highly preferred., • Working knowledge of FDA regulations, cGMP, GDP, packaging operations, labeling controls, AQL inspection, material reconciliation, and shipment/dispatch controls., • Strong attention to detail with the ability to identify documentation, process, and compliance discrepancies in real time., • Ability to work effectively in a fast-paced pharmaceutical manufacturing environment and collaborate with cross-functional teams., • Strong written and verbal communication skills., • Ability to independently perform QA assessments within established procedures and appropriately escalate issues when required., • Experience supporting FDA Pre-Approval Inspections (PAI) or routine GMP inspections is preferred. 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 $85,000 - $95,000 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 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:\n\nAbout the Company:\nNivagen 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.\nJob Location:\nNivagen Pharmaceuticals\n3900 Duckhorn Dr, Sacramento, CA 95834.\nAbout the Job: \nThe Director of Engineering, Maintenance & Reliability is accountable for the technical performance, compliance, reliability, and lifecycle management of the site's aseptic manufacturing assets, and operational technology. The operation manufactures sterile liquid products in multiple presentations, including prefilled syringes, vials, and preformed bags, using isolators, Restricted Access Barrier Systems (RABS), formulation and filtration tanks, aseptic filling and sealing equipment, classified cleanrooms, and critical utilities.\nThis leader builds and directs the organization responsible for manufacturing and process engineering, automation and operational technology, maintenance execution, reliability engineering, capital projects, and asset lifecycle and obsolescence management.\nThe Director ensures that equipment, automation, and maintenance practices remain safe, reliable, qualified, validated, inspection-ready, and capable of meeting production requirements. The role partners closely with Manufacturing, Quality Assurance, Validation, Sterility Assurance, Microbiology, Environmental Health and Safety, Supply Chain, Information Technology, Finance, and corporate engineering.\nThis position requires a leader who can balance patient safety, product quality, sterility assurance, regulatory compliance, equipment availability, operational performance, and cost management in a highly regulated aseptic manufacturing environment.\nResponsibilities:\n1. Engineering Leadership and Organizational Development\n\n Lead the site Engineering, Maintenance, and Reliability organization and establish clear accountability for GMP-critical assets and systems.\n Develop an organizational structure that provides effective ownership of aseptic filling and packaging equipment, isolators and RABS, formulation and filtration systems, cleanrooms and HVAC, clean utilities, automation and OT systems, maintenance, reliability, calibration, and capital projects.\n Recruit, develop, coach, and retain engineers, maintenance technicians, reliability professionals, automation specialists, planners, supervisors, and technical subject-matter experts.\n Define technical ownership, escalation paths, decision rights, performance expectations, training requirements, and qualification standards.\n Build technical depth, succession plans, and sustainable internal capability for critical systems while using contractors and OEM support effectively.\n Promote a culture of safety, quality, disciplined execution, timely escalation, continuous improvement, and proactive risk management.\n\n2. Aseptic Manufacturing Equipment\n\n Provide technical leadership and lifecycle ownership for syringe, vial, and preformed bag filling and closure systems; isolators; RABS; decontamination systems; component handling; inspection; leak testing; and associated support equipment.\n Ensure equipment design, operation, maintenance, and modification support aseptic processing requirements and the site Contamination Control Strategy.\n Drive reduction of equipment-related interventions, contamination risks, recurring failures, minor stops, rejects, and changeover losses within critical aseptic operations.\n Establish technical strategies for barrier pressure control, glove integrity testing, isolator leak testing, decontamination-cycle performance, transfer systems, alarms, interlocks, and equipment recovery following intrusive maintenance.\n Ensure maintenance methods protect critical surfaces, HEPA filters, glove systems, pressure boundaries, sterile pathways, and decontamination capability.\n Improve filling-line availability, throughput, yield, and reliability without compromising sterility assurance, product quality, data integrity, or validated operation.\n\n3. Formulation, Compounding, and Sterile Filtration Systems\n\n Provide engineering ownership for formulation, compounding, hold, and filtration systems, including stainless-steel tanks, agitation, load cells, temperature control, transfer piping and hoses, filters, vents, and associated instrumentation.\n Ensure hygienic design, cleanability, sterilizability, drainability, material compatibility, and maintainability of product-contact systems.\n Partner with Process Engineering, Manufacturing, Quality, Validation, and Sterility Assurance to maintain control of mixing parameters, hold times, product temperature, sterile filtration conditions, filter integrity testing, and aseptic transfers.\n Provide technical oversight for clean-in-place, steam-in-place, single-use assemblies, sterile connectors, and product-contact change parts, where applicable.\n Lead or support investigations involving mixing variability, filter failures, integrity-test failures, equipment residues, tank or piping contamination, transfer losses, and other process-equipment issues.\n\n4. Maintenance Management\n\n Own the site maintenance program for GMP and non-GMP assets, including preventive, predictive, condition-based, corrective, and emergency maintenance.\n Establish disciplined planning and scheduling, job plans, work-order prioritization, weekly scheduling, shutdown planning, backlog management, kitting, spare-parts control, and maintenance standard work.\n Improve schedule compliance and planned-work percentage while reducing reactive and emergency maintenance.\n Ensure maintenance work protects product, cleanroom classification, contamination controls, qualified systems, and validated state.\n Define requirements for equipment cleaning, disinfection, inspection, line clearance, functional testing, documentation, and release following maintenance.\n Establish controls for tools, lubricants, replacement parts, temporary repairs, foreign-material risks, and work within classified or product-contact areas.\n Ensure maintenance records are complete, accurate, timely, attributable, and inspection-ready.\n Manage maintenance contractors and service providers in accordance with site safety, quality, security, and contamination-control requirements.\n\n5. Reliability Engineering\n\n Develop and execute a site reliability strategy for manufacturing equipment, facilities, utilities, instrumentation, and automation.\n Establish asset criticality based on patient safety, product quality, sterility assurance, regulatory compliance, personnel safety, production continuity, and business impact.\n Apply reliability-centered maintenance, failure modes and effects analysis, root cause analysis, bad-actor analysis, condition monitoring, defect elimination, and critical-spares analysis.\n Identify chronic failures and implement permanent engineering solutions rather than repeated short-term repairs.\n Lead equipment health reviews and reliability improvement plans for critical systems using downtime, failure, alarm, intervention, and maintenance-history data.\n Manage lifecycle and obsolescence risks for PLCs, control hardware, instrumentation, isolator components, filling systems, utilities, and long-lead assets.\n Develop business continuity, recovery, and contingency plans for failures that could interrupt sterile manufacturing.\n\n6. Automation and Operational Technology\n\n Provide governance and technical leadership for PLCs, HMIs, SCADA, building management systems, data historians, environmental and facility monitoring interfaces, equipment recipes, alarms, and interlocks.\n Establish clear ownership and support models across Engineering, Automation, Quality, Validation, Information Technology, and equipment vendors.\n Ensure automation systems remain secure, supported, backed up, recoverable, appropriately accessed, and maintained under configuration and change control.\n Manage automation lifecycle, software and firmware obsolescence, backups, disaster recovery, patching, user access, and system documentation.\n Partner with IT and cybersecurity resources to maintain appropriate OT network architecture and cybersecurity controls without compromising safety, uptime, or validated operation.\n Ensure changes to control logic, recipes, alarms, interlocks, interfaces, and user access are assessed, tested, approved, documented, and validated as required.\n\n7. Capital Projects and Asset Lifecycle Management\n\n Develop and execute the site capital plan for capacity, compliance, reliability, obsolescence, safety, sustainability, and cost improvement.\n Translate operational needs into user requirements, concepts, project scopes, schedules, budgets, and business cases.\n Provide technical oversight through feasibility, design, procurement, FAT, SAT, installation, commissioning, qualification, handover, and performance verification.\n Ensure new equipment and modifications incorporate aseptic design, contamination control, hygienic design, maintainability, reliability, safe access, automation, and cybersecurity requirements.\n Engage Engineering and Maintenance early in project design to prevent difficult-to-operate, difficult-to-maintain, or unreliable systems.\n Manage project risks, vendors, technical deliverables, cost, schedule, and turnover requirements, including documentation, spare parts, training, maintenance plans, calibration, and system ownership.\n\n8. Compliance and Quality Systems\n\n Ensure engineering and maintenance activities comply with cGMP requirements, approved procedures, specifications, regulatory commitments, and company quality systems.\n Maintain facilities, utilities, equipment, instrumentation, and automation systems in their qualified and validated state.\n Ensure effective execution of change controls, deviations, investigations, CAPAs, engineering assessments, risk assessments, periodic reviews, and maintenance and calibration documentation.\n Partner with Quality, Validation, Manufacturing, Microbiology, and Sterility Assurance on events that may affect product quality or aseptic control.\n Provide engineering support during aseptic process simulations and evaluate equipment-related interventions, alarms, failures, and atypical events.\n Represent Engineering and Maintenance during regulatory inspections, customer audits, and internal audits.\n Ensure observations, commitments, and CAPAs are addressed thoroughly, technically, and on schedule.\n\n9. Operational Excellence and Performance Improvement\n\n Establish performance metrics and management routines for Engineering, Maintenance, Reliability, Automation, Utilities, and Calibration.\n Reduce unplanned downtime, chronic minor stops, equipment interventions, repeat failures, maintenance-related deviations, excessive changeover time, and utility excursions.\n Use operational, quality, automation, and maintenance data to identify trends, prioritize risk, and target improvement resources.\n Partner with Manufacturing to improve overall equipment effectiveness while protecting aseptic control and validated operation.\n Implement tiered accountability, visual management, standard work, structured problem-solving, and effective escalation.\n Evaluate predictive maintenance, condition monitoring, remote diagnostics, and equipment-data analytics where they provide appropriate value.\n\n10. Financial, Vendor, and Resource Management\n\n Develop and manage Engineering and Maintenance operating budgets and long-range capital and asset lifecycle forecasts.\n Optimize the mix of internal resources, OEM support, service agreements, contractors, and third-party technical services.\n Evaluate total cost of ownership when making equipment, replacement, spare-parts, service, and staffing decisions.\n Establish governance and performance expectations for critical equipment vendors and service providers.\n Identify cost and productivity improvements without increasing safety, quality, contamination, compliance, reliability, or supply risk.\n\nSupervisory Responsibilities\nThis position has direct supervisory responsibility for leaders and individual contributors within Engineering, Maintenance, Reliability, Automation/OT, Facilities and Utilities, Calibration/Metrology, and Capital Projects, as assigned. The position is also responsible for technical direction of contractors, vendors, OEM personnel, and project teams.\nLeadership Expectations\n\n Place patient safety, product quality, sterility assurance, and personnel safety at the center of engineering decisions.\n Maintain a visible presence in manufacturing and regularly observe equipment operation and maintenance work at the point of execution.\n Demonstrate calm, decisive technical judgment during operational disruptions, quality events, and major equipment failures.\n Communicate technical issues, operational consequences, options, and business risks clearly to senior leadership.\n Create accountability while encouraging timely escalation and transparent reporting of risk.\n Build trusted partnerships across Manufacturing, Quality, Validation, Sterility Assurance, EHS, Supply Chain, Finance, IT, and corporate functions.\n Move the organization from reactive maintenance toward proactive reliability, defect elimination, and lifecycle management.\n Develop people and sustainable technical capability rather than relying excessively on individual experts, contractors, or vendors.\n\nNon-Essential Functions\n\n Support network and corporate engineering initiatives, technical standards, due diligence, and benchmarking activities.\n Participate in Lean, 5S, sustainability, energy-management, and operational-excellence programs.\n Prepare technical presentations, budget proposals, risk summaries, and management updates.\n Perform other duties as assigned based on business needs.\n\nEducation/Experience: \n\n Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, Controls Engineering, or a relate

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 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: The Automation & Controls Engineer – Aseptic & Packaging Systems is responsible for supporting, maintaining, troubleshooting, and improving automation and control systems used in a cGMP pharmaceutical manufacturing environment. This role supports aseptic processing, sterile filling, inspection, packaging, utilities, and facility automation systems. The Automation & Controls Engineer provides technical ownership and support for systems such as PLCs, HMIs, SCADA, manufacturing equipment controls, vision systems, serialization systems, data historians, robotics, motion control, building automation interfaces, and equipment network infrastructure. This position works cross-functionally with Manufacturing, Maintenance, Quality Assurance, Validation, Engineering, IT/OT, Facilities, Packaging, and Equipment Vendors to ensure automated systems operate safely, reliably, and in compliance with GMP, data integrity, validation, computerized system, and change control requirements. Responsibilities: • Provide daily technical support for automation and control systems used in pharmaceutical manufacturing, packaging, inspection, and facility operations., • Troubleshoot PLC, HMI, SCADA, servo, motion control, robotics, vision, and equipment communication issues., • Supporting automated equipment used for aseptic formulation, sterile filling, vials, syringes, cartridges, flexible containers/bags, inspection, labeling, packaging, serialization, and aggregation., • Diagnose and resolve automation-related downtime events to support production schedules., • Provide on-floor engineering support during startup, shutdown, changeover, and active manufacturing operations., • Develop, modify, test, and troubleshoot PLC and HMI applications in accordance with site standards and change control requirements., • Support PLC platforms such as Allen-Bradley / Rockwell Automation, Siemens, or equivalent systems., • Support HMI/SCADA platforms such as FactoryTalk View, WinCC, Ignition, iFIX, Wonderware, or similar systems., • Review and interpret ladder logic, function block diagrams, structured text, control narratives, electrical drawings, and automation design documentation., • Maintain current backups of validated automation programs and configuration files., • Ensure automation work is performed in compliance with cGMP, GDP, data integrity, 21 CFR Part 11, computerized system validation, and company quality system requirements., • Support validation deliverables including user requirements specifications, functional specifications, design specifications, configuration specifications, commissioning protocols, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports., • Partner with Validation and Quality Assurance to ensure automation changes are properly assessed, tested, documented, and approved., • Maintain the validated state of computerized and automated systems., • Support audit readiness for automation-related systems and records., • Support automation integration for new and existing manufacturing equipment., • Work with OEMs and internal teams during equipment design, FAT, SAT, commissioning, qualification, and startup., • Support equipment interfaces with MES, ERP/SAP, SCADA, data historians, serialization systems, vision inspection systems, and building automation systems., • Troubleshoot communication protocols such as Ethernet/IP, Profinet, Modbus, OPC, serial communication, and industrial network connectivity., • Support alarm configuration, data collection, recipe management, batch reporting, and equipment status reporting., • Support automation systems associated with isolators, Restricted Access Barrier Systems, vial filling lines, syringe filling lines, cartridge filling systems, flexible container/bag filling systems, cappers, labelers, cartoners, case packers, conveyors, vision inspection systems, and serialization/aggregation equipment., • Support VHP cycle automation, environmental monitoring interfaces, equipment alarms, and electronic records where applicable., • Partner with Manufacturing and Maintenance to resolve recurring automation or equipment control issues., • Support packaging line control systems, printer/labeler interfaces, barcode verification, serialization reporting, and aggregation workflows., • Help maintain equipment controls in an inspection-ready and production-ready state., • Initiate, assess, and execute automation-related change controls in accordance with site procedures., • Support investigations for deviations, equipment failures, batch interruptions, automation alarms, data integrity concerns, and system performance issues., • Participate in root cause analysis and develop corrective and preventive actions related to control systems., • Document technical assessments, impact evaluations, test results, and implementation plans., • Ensure automation changes are properly reviewed, approved, tested, and closed., • Support automation preventive maintenance activities, including backup verification, network health checks, control cabinet inspections, UPS checks, and HMI/PLC health monitoring., • Identify opportunities to improve equipment reliability, uptime, alarm management, and system robustness., • Analyze recurring automation failures and recommend long-term corrective actions., • Support spare parts strategy for control system components., • Participate in reliability improvement and continuous improvement projects., • Support compliance with data integrity expectations for electronic records, audit trails, user access, time synchronization, recipe management, and backup/restore controls., • Partner with IT/OT teams to maintain secure, reliable industrial control system networks., • Support user access reviews, account management, system backup, patching, disaster recovery, and cybersecurity initiatives., • Ensure automation systems are maintained in accordance with company IT/OT standards and GMP requirements., • Support system lifecycle management, obsolescence planning, and periodic review activities., • Create and maintain automation documentation including control narratives, functional specifications, system architecture diagrams, network diagrams, I/O lists, alarm lists, recipe/configuration documentation, and backup/recovery procedures., • Maintain automation-related SOPs, work instructions, troubleshooting guides, and support documentation., • Ensure technical documentation reflects current system configuration and validated state., • Support training for Maintenance, Manufacturing, Engineering, and other system users., • Provide technical standards input for new equipment and automation projects. Education/Experience: • Bachelor's degree in Electrical Engineering, Automation Engineering, Controls Engineering, Computer Engineering, Mechanical Engineering, Chemical Engineering, or related technical discipline required., • Equivalent combination of education, training, and relevant automation experience may be considered., • Minimum of 3–5 years of automation, controls, or manufacturing engineering experience in a regulated manufacturing environment preferred., • Experience supporting pharmaceutical, biotechnology, medical device, food, chemical, or other GMP-regulated manufacturing operations preferred., • Experience with PLC/HMI troubleshooting, programming, and system support required., • Experience supporting automated manufacturing or packaging equipment preferred. Preferred Qualifications: • Experience in sterile manufacturing, aseptic fill/finish, biologics, parenteral manufacturing, or packaging operations., • Experience with isolators, RABS, VHP systems, filling lines, inspection systems, labeling systems, serialization systems, or packaging automation., • Experience with platforms such as Allen-Bradley / Rockwell Automation, Siemens, FactoryTalk View, WinCC, Ignition, Wonderware, OSIsoft PI or other data historians, Cognex, Keyence, Antares, Optel, TraceLink, or similar systems., • Experience with MES, SAP, ERP interfaces, and electronic batch record systems., • Experience with 21 CFR Part 11, GAMP 5, computerized system validation, and audit trail review., • Experience supporting FAT, SAT, IQ, OQ, PQ, and process validation., • Experience with industrial cybersecurity, OT networks, virtualized systems, and backup/recovery strategies., • Lean Six Sigma, ISA, Rockwell, Siemens, or automation-related certifications preferred. Physical Requirements/ Working Conditions: • Ability to sit, stand, walk, bend, reach, kneel, and climb as needed to access equipment and control panels., • Ability to work at a computer workstation for extended periods., • Ability to visually inspect equipment screens, control panels, wiring, labels, documentation, and HMI displays., • Ability to lift, carry, push, or pull tools, laptops, test equipment, or components up to 25–50 pounds, in accordance with site safety procedures., • Ability to wear required PPE, including cleanroom gowning, safety glasses, gloves, hearing protection, or other protective equipment., • Ability to enter cleanrooms, manufacturing suites, packaging areas, utility spaces, and equipment rooms as required., • Ability to work overtime, weekends, holidays, alternative shifts, or on-call support as business needs require. Work Environment • Work is performed in a GMP pharmaceutical manufacturing facility, including office areas, manufacturing areas, cleanrooms, packaging areas, equipment rooms, and utility areas., • Work may occur near operating equipment, automated machinery, electrical panels, moving parts, compressed air, controlled environments, and production materials., • The role may require entry into Grade B, Grade C, Grade D, and controlled support areas, depending on production and equipment needs., • Strict adherence to GMP, safety, gowning, contamination control, lockout/tagout, electrical safety, and documentation procedures are required., • This position requires on-site presence; limited remote work may be possible depending on business needs and company policy. Schedule / Shift Requirements • Standard business hours are typical, but support may be required outside normal hours based on production needs., • Overtime, weekends, holidays, shutdown coverage, project support, and on-call support may be required., • Must be able to support urgent equipment issues, manufacturing campaigns, validation activities, and planned maintenance windows. Requirements: • 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) Benefits: • Competitive Salary: Based on Experience, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including medical, dental, and vision coverage, • Sick Time/PTO 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:\n\nAbout the Company:\nNivagen 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.\nJob Location:\nNivagen Pharmaceuticals Inc., Sacramento, CA\n3900 Duckhorn Dr, Sacramento, CA 95834.\nAbout the Job:\nJob Title: Aseptic Process Engineer \nDepartment: Manufacturing Science & Technology\nReports to: Process Engineering Manager \n \nJob Summary: The Aseptic Process Engineer is responsible for providing technical process ownership and engineering support for sterile pharmaceutical manufacturing operations in a cGMP-regulated environment. This role supports aseptic formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging processes for vials, prefilled syringes, cartridges, and flexible containers/bags.\nThe Aseptic Process Engineer partners with Manufacturing, Quality Assurance, Validation, Engineering, Maintenance, Automation, Supply Chain, and Technical Operations to ensure aseptic processes are robust, compliant, efficient, and maintained in a state of control. This position supports process troubleshooting, deviation investigations, CAPAs, change controls, process validation, media fills, technology transfer, equipment/process improvements, and contamination control initiatives.\nThis role requires strong technical knowledge of aseptic processing, sterile drug product manufacturing, cGMP requirements, contamination control, process validation, and manufacturing floor execution in classified cleanroom environments.\nResponsibilities:\n\n Provide technical support for aseptic manufacturing processes including formulation, sterile filtration, product transfer, aseptic filling, stoppering, capping, sealing, and related fill/finish operations.\n Support sterile drug product formats including vials, prefilled syringes, cartridges, and flexible containers/bags.\n Serve as a technical resource for Manufacturing during batch execution, process setup, line start-up, changeover, and shutdown activities.\n Evaluate process performance and identify opportunities to improve robustness, yield, throughput, right-first-time execution, and contamination control.\n Support process readiness activities including procedures, batch records, training, equipment setup, materials, and critical process parameters.\n Provide technical support for operations performed in Grade A, B, C, D, and controlled manufacturing areas, as applicable.\n Support contamination control strategy implementation, including aseptic behaviors, cleanroom practices, intervention management, airflow considerations, and process risk reduction.\n Participate in aseptic process simulations, media fills, smoke studies, airflow visualization activities, and contamination control assessments.\n Assess process interventions, line design, personnel interactions, material movement, and equipment interactions for contamination risk.\n Partner with Manufacturing, Microbiology, Quality Assurance, and Validation to investigate environmental monitoring trends, sterility-related events, and aseptic process concerns.\n Monitor process performance using batch data, process parameters, yield data, reject trends, downtime data, and quality metrics.\n Troubleshoot process issues and provide technical recommendations during manufacturing interruptions, equipment challenges, or batch deviations.\n Perform data analysis to identify trends, root causes, and improvement opportunities.\n Support process optimization activities for formulation, fill volume control, filtration, product transfer, component handling, and filing performance.\n Develop and implement process improvements to reduce deviations, improve efficiency, and maintain product quality.\n Lead or support technical investigations for deviations, process excursions, contamination events, equipment-related events, batch interruptions, and quality issues.\n Perform root cause analysis using appropriate tools and document technical assessments in accordance with site quality procedures.\n Develop, implement, and verify corrective and preventive actions related to aseptic manufacturing processes.\n Initiate, assess, and execute change controls for process improvements, equipment modifications, procedural changes, and new product/process introductions.\n Ensure technical conclusions, impact assessments, and risk evaluations are well documented and aligned with GMP expectations.\n Support process validation, cleaning validation, sterilization validation, filter validation, and continued process verification activities as applicable.\n Author, review, and execute validation-related documents including protocols, reports, process risk assessments, sampling plans, and summary reports.\n Support process performance qualification, engineering runs, media fills, and commercial process monitoring.\n Evaluate validation data and process capability to ensure processes remain in a state of control.\n Partner with Validation, Quality, Manufacturing, and Engineering to maintain process validation lifecycle documentation.\n Support technology transfer and new product introduction activities for sterile drug product manufacturing processes.\n Translate process requirements into manufacturing instructions, equipment needs, facility requirements, batch records, and process parameters.\n Participate in process fit assessments, gap assessments, risk assessments, and manufacturing readiness reviews.\n Support engineering runs, clinical or commercial scale-up, process comparability assessments, and launch readiness activities.\n Collaborate with development, MSAT, Quality, Validation, Supply Chain, and Manufacturing to ensure successful process implementation.\n Provide process engineering support for aseptic processing equipment, including isolators, Restricted Access Barrier Systems, filling lines, pumps, filtration systems, stopper/cap handling systems, bag filling systems, and related support equipment.\n Support equipment design reviews, user requirements, commissioning, qualification, FAT/SAT, and operational readiness activities.\n Partner with Maintenance, Automation, Facilities, and Engineering to resolve process-equipment interface issues.\n Support process requirements for cleanrooms, utilities, environmental controls, sterilization/decontamination systems, and product-contact equipment.\n Help define and maintain process-critical equipment parameters, alarms, recipes, and operational limits.\n Author and review GMP documents including SOPs, batch records, protocols, technical reports, change controls, deviations, CAPAs, risk assessments, and process descriptions.\n Ensure process documentation accurately reflects approved manufacturing processes and current operational practices.\n Support documentation updates related to process improvements, investigations, validation outcomes, and regulatory commitments.\n Maintain compliance with cGMP, GDP, data integrity, validation, and company quality system expectations.\n Support regulatory inspections, customer audits, internal audits, and inspection readiness activities as needed.\n Partner with Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance, Automation, Supply Chain, and Technical Operations to resolve process-related issues.\n Provide technical training and process knowledge transfer to Manufacturing Technicians, Supervisors, and support teams.\n Participate in production meetings, tier meetings, deviation review boards, validation meetings, and project meetings.\n Communicate process risks, technical recommendations, and project status clearly to stakeholders.\n Promote a culture of safety, quality, compliance, and continuous improvement.\n\nRequired Knowledge/Skills/Abilities:\n\n Strong understanding of aseptic processing, sterile drug product manufacturing, contamination control, and cGMP requirements.\n Working knowledge of formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging interfaces.\n Ability to troubleshoot process issues and apply structured root cause analysis tools.\n Ability to analyze manufacturing data, process trends, deviations, and performance metrics.\n Strong technical writing skills for investigations, reports, protocols, SOPs, batch records, and change controls.\n Knowledge of process validation, cleaning validation, computerized systems, and continued process verification concepts preferred.\n Strong communication, collaboration, and project execution skills.\n Ability to work effectively on the manufacturing floor and with cross-functional teams in a fast-paced GMP environment.\n Proficiency with Microsoft Word, Excel, PowerPoint, and data analysis tools.\n\nEducation and Experience:\n\n Bachelor's degree in chemical engineering, Biochemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Life Sciences, or related technical discipline required.\n Advanced degree in engineering, pharmaceutical sciences, biotechnology, or related discipline preferred.\n Minimum of 3–5 years of experience in pharmaceutical, biotechnology, biologics, medical device, or regulated manufacturing environment preferred.\n Experience supporting sterile manufacturing, aseptic fill/finish, formulation, process engineering, MSAT, validation, or technical operations strongly preferred.\n Experience with aseptic processing for vials, prefilled syringes, cartridges, or flexible containers/bags preferred.\n Experience supporting deviations, CAPAs, change controls, process validation, or technology transfer in a GMP environment preferred.\n\nPhysical Requirements/ Working Conditions: \n\n Ability to sit, stand, walk, bend, reach, and climb stairs as needed to support manufacturing and engineering activities.\n Ability to work at a computer workstation for extended periods.\n Ability to enter manufacturing suites, cleanrooms, packaging areas, utility spaces, and equipment rooms as required.\n Ability to wear required PPE and cleanroom gowning for extended periods when supporting classified areas.\n Ability to visually inspect equipment, materials, documentation, process conditions, and computer screens.\n Ability to lift, carry, push, or pull materials, laptops, sample containers, or equipment components up to 25 pounds as needed.\n Ability to work overtime, weekends, holidays, alternative shifts, or on-call support as business needs require.\n\nWork Environment\n\n Work is performed in a GMP pharmaceutical manufacturing facility, including office areas, cleanrooms, manufacturing suites, packaging areas, laboratories, equipment rooms, and utility spaces.\n The role may require entry into Grade A, B, C, D, and controlled support areas depending on process and production needs.\n Work may occur near operating equipment, automated machinery, disinfectants, production materials, controlled temperatures, and cleanroom environments.\n Strict adherence to GMP, safety, gowning, hygiene, contamination control, and documentation procedures is required.\n This position requires regular on-site presence; limited remote work may be possible depending on business needs and company policy.\n\nSchedule / Shift Requirements\n\n Standard business hours are typical, but support may be required outside normal hours based on production needs.\n Overtime, weekends, holidays, shutdown coverage, and on-call support may be required.\n Must be able to support urgent process issues, manufacturing campaigns, validation activities, engineering runs, and planned production or maintenance windows.\n\nRequirements:\n\n Valid driver's license and acceptable driving record\n Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents)\n Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius)\n\nBenefits:\n\n Competitive Salary (Based on Experience)\n Yearly bonus eligibility\n Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage\n Paid time off plan\n\nAdditional Information:\nNivagen 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 More 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 commercial-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 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 Technician, Facilities/Maintenance - Night Shift is responsible for supporting the maintenance and repair of facilities and associated infrastructure across multiple production sites producing clinical and commercial drug products. This role involves utilization of a Computerized Maintenance Management System (CMMS) to execute and document preventative and corrective maintenance activities to ensure compliant and reliable operations to support production requirements to meet customer needs. Night Shift Hours Worked: • 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 Wednesday Physical Demands & Work Conditions • 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 meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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., • Must be comfortable regularly participating in video-based meetings.Job Duties and Key Responsibilities, • Perform or coordinate preventive and corrective maintenance on the facility and associated infrastructure, • Coordinate onsite preventative and corrective maintenance to be completed by service providers, • Escort of service providers in restricted access areas during execution of facility and asset maintenance activities, • Review and approval of service provider documentation, and completion of tasks in the CMMS, • Maintain documentation in accordance with company standards, • Ensure that facilities and associated infrastructure are maintained to applicable regulatory and GMP requirements, • Participate in the continuous improvement of facility standards, specifications, procedures, and business processes, • Other duties as assigned, • Respond to emergency maintenance requests during off-hours as neededEducation & Experience Requirements, • High school diploma or GED required, associate’s degree or certification in facility maintenance preferred, • 2 years of experience in GMP manufacturing facility, preferably cell therapy, biotechnology or pharmaceutical, • Experience in use of a CMMS system for managing execution of maintenance activities, • Experience in execution of preventative and corrective maintenance of a GMP manufacturing facility and associated infrastructure, • Experience coordinating onsite maintenance activities completed by service providersPersonal Qualities & Physical Demands, • Ability to multitask and manage multiple responsibilities simultaneously; able to prioritize, • Demonstrates strong work ethic and problem-solving skills, • Willing to support sites after-hours on an as needed or on-call basis, • Strong people skills and ability to communicate effectively, • Ability to gown and work in cleanroom areas, • Ability to work in a collaborative manner, independently and as part of a team, • Ability to work in a fast-paced start-up environment while following documented procedures and instructions., • Ascend/descend stairs within the workspace; job requires sitting, standing, walking Base hourly pay range: $28–$32. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials. The anticipated annual salary range (listed above) 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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 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 Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Equipment Maintenance Technician – Aseptic & Packaging Systems Department: Maintenance/Engineering/Manufacturing Operations Reports to: Maintenance Supervisor/ Facilities & Engineering Manager Job Summary: The Equipment Maintenance Technician - Aseptic & Packaging Systems is responsible for performing preventive maintenance, corrective maintenance, troubleshooting, repairs, and technical support for manufacturing equipment used in a cGMP-regulated pharmaceutical manufacturing environment. This role supports aseptic processing, sterile filling, inspection, packaging, and related manufacturing operations. Equipment may include isolators, Restricted Access Barrier Systems (RABS), vial filling lines, syringe filling systems, cartridge equipment, flexible container/bag filling systems, pumps, conveyors, cappers, labelers, serialization systems, inspection equipment, and packaging equipment. The Equipment Maintenance Technician plays a critical role in maintaining equipment reliability, minimizing downtime, supporting production schedules, and ensuring work is performed safely and in compliance with GMP, GDP, safety, and data integrity requirements. Responsibilities: • Perform preventive, corrective, and emergency maintenance on pharmaceutical manufacturing equipment., • Troubleshoot and repair mechanical, electrical, pneumatic, hydraulic, and automated equipment issues., • Support equipment used in formulation, sterile filling, inspection, packaging, labeling, and material handling operations., • Perform equipment setup, adjustments, alignments, component replacement, lubrication, calibration support, and functional testing., • Respond to production equipment breakdowns and support timely return to service., • Maintain and support equipment used in aseptic manufacturing environments, including isolators, Restricted Access Barrier Systems, vial filling equipment, prefilled syringe filling equipment, cartridge filling systems, flexible container/bag filling systems, and stoppering, capping, sealing, and closure systems., • Support production equipment operating in or adjacent to Grade B, Grade C, Grade D, and controlled manufacturing areas., • Follow cleanroom gowning, contamination control, and aseptic behavior requirements when performing work in classified areas., • Support equipment readiness, line clearance, changeover, startup, and shutdown activities., • Coordinate with Manufacturing, Quality Assurance, Engineering, Validation, Automation, and Facilities to maintain compliant equipment operation., • Maintain and troubleshoot packaging and inspection equipment including labelers, cartoners, case packers, conveyors, vision inspection systems, serialization and aggregation systems, checkweighers, and coding systems., • Support packaging line changeovers, format part changes, setup verification, and operational troubleshooting., • Assist Manufacturing and Packaging teams during equipment startup and routine production execution., • Support inspection and packaging equipment readiness for GMP production and line clearance activities., • Escalate equipment issues that may impact product quality, labeling accuracy, serialization integrity, or batch execution., • Complete maintenance documentation accurately, contemporaneously, and in accordance with Good Documentation Practices., • Document work orders, parts usage, equipment history, and maintenance activities in CMMS such as SAP PM, Maximo, Blue Mountain, or equivalent system., • Follow approved SOPs, maintenance procedures, safety procedures, and equipment manuals., • Identify and escalate GMP-impacting equipment issues, deviations, or abnormal conditions., • Support deviation investigations, CAPAs, change controls, audit readiness, and inspection activities as required., • Diagnose equipment failures and determine appropriate corrective actions., • Use technical manuals, schematics, drawings, wiring diagrams, P&IDs, and equipment documentation to support troubleshooting., • Assist with root cause analysis for recurring equipment failures or production interruptions., • Partners with Manufacturing, Quality Assurance, Engineering, Automation, Validation, and Facilities teams to resolve equipment issues., • Support equipment improvements, reliability initiatives, and continuous improvement projects., • Execute scheduled preventive maintenance tasks in accordance with approved procedures and maintenance plans., • Identify opportunities to improve preventive maintenance frequency, scope, and effectiveness., • Support reliability improvement activities to reduce downtime, repeat failures, and production interruptions., • Assist with installation, commissioning, qualification, and startup of new or modified equipment., • Maintain tools, parts, equipment, and maintenance areas in an organized and inspection-ready condition., • Follow all site safety procedures, lockout/tagout requirements, electrical safety practices, chemical handling requirements, and PPE requirements., • Safely work around operating equipment, moving parts, compressed air, utilities, and controlled environments., • Maintain a safe, clean, and organized work area., • Participate in safety investigations, near-miss reporting, and continuous improvement initiatives., • Support a culture of safety, quality, compliance, and operational excellence. Education/Experience: • High school diploma or GED required., • Associate degree, technical certificate, trade school certification, or equivalent training in industrial maintenance, mechanical technology, electrical technology, automation, manufacturing technology, or related field preferred., • Minimum of 2-5 years of maintenance experience in pharmaceutical, biotechnology, medical device, food, chemical, semiconductor, or other regulated manufacturing environment preferred., • Experience maintaining manufacturing, packaging, or automated production equipment required., • Experience working in a GMP-regulated environment preferred., • Experience supporting aseptic processing, sterile manufacturing, or cleanroom equipment strongly preferred. Preferred Qualifications: • Experience with aseptic filling equipment for vials, syringes, cartridges, or flexible containers/bags., • Experience with isolators, RABS, VHP systems, sterile barriers, or cleanroom equipment., • Experience with packaging equipment, labeling systems, vision systems, serialization, and aggregation systems., • Familiarity with PLC/HMI troubleshooting, preferably Allen-Bradley, Siemens, or similar platforms., • Experience with SAP PM, Maximo, Blue Mountain, or equivalent CMMS., • Experience supporting equipment qualification, validation, FAT/SAT, or commissioning activities., • Knowledge of lockout/tagout, electrical safety, confined space, and hazardous energy control., • Experience in sterile drug product, biologics, vaccines, or parenteral manufacturing. Physical Requirements/ Working Conditions: • Ability to stand, walk, bend, stoop, kneel, crouch, crawl, climb, and reach during maintenance activities., • Ability to lift, carry, push, or pull tools, parts, and equipment up to 25-50 pounds, in accordance with site safety procedures., • Ability to work around moving machinery, conveyors, pumps, motors, utilities, and production equipment., • Ability to use hand tools, power tools, meters, diagnostic equipment, and maintenance instruments., • Ability to wear required PPE, including safety glasses, gloves, hearing protection, cleanroom gowning, and respiratory protection where required., • Ability to work in cleanroom gowning for extended periods., • Ability to visually inspect equipment, components, labels, documentation, and equipment status indicators., • Ability to work overtime, weekends, holidays, alternative shifts, or on-call assignments as business needs require. Work Environment • Work is performed in a GMP pharmaceutical manufacturing facility, including production areas, packaging areas, maintenance shops, utility spaces, cleanrooms, and controlled environments., • Work may occur in Grade B, Grade C, Grade D, and support areas depending on equipment and production needs., • The work environment may include exposure to operating equipment, moving parts, compressed air, cleaning agents, disinfectants, controlled temperatures, noise, and manufacturing materials., • Strict adherence to gowning, hygiene, safety, contamination control, and documentation procedures is required., • This position requires on-site presence and is not eligible for remote work. Schedule / Shift Requirements • Position is for 2nd Shift ONLY (230 PM-10:00 PM) Benefits: • Pay range: Competitive Salary, • 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 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.

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Sacramento, California, United States $ 49.99 - 99.99 (US Dollar) Job Title: Remote Virtual Assistant Company: Aniesispharma, LLC Location: Remote (work from home) Job Type: Full-time/Part-time, flexible hours About Us: Aniesispharma is a rapidly growing pharmaceutical company dedicated to developing innovative medicines that improve patients' lives worldwide. We're seeking a highly skilled and organized virtual assistant to support our team remotely. Job Summary: As a remote virtual assistant, you'll provide administrative support to our team, managing tasks, projects, and communications. Your role will be crucial in ensuring the smooth operation of our business and enabling our team to focus on their core responsibilities. Responsibilities: • Manage email correspondence, calendar organization, and scheduling appointments, • Provide data entry, record-keeping, and document management support, • Conduct research, gather information, and summarize findings, • Handle phone calls, messages, and correspondence, • Maintain organized digital files and databases, • Support project management, including task assignment and tracking, • Collaborate with team members to achieve business objectives, • Perform other administrative tasks as needed Requirements: • 1-2 years of experience as a virtual assistant or administrative role, • Excellent communication, organizational, and time management skills, • Proficiency in Google Suite, Microsoft Office, or similar tools, • Ability to work independently and manage multiple tasks, • Strong attention to detail and problem-solving skills, • Reliable internet connection and quiet work environment, • Familiarity with pharmaceutical industry or healthcare sector (preferred) Nice to Have: • Experience with project management tools like Trello, Asana, or Basecamp, • Knowledge of CRM software like HubSpot or Salesforce, • Familiarity with document management systems What We Offer: • Competitive hourly rate, • Flexible hours and remote work arrangement, • Opportunity to work with a dynamic and growing company, • Professional development and growth opportunities If you're a highly organized and skilled virtual assistant looking for a challenging and rewarding role, we'd love to hear from you!

Job DescriptionJob Title: Automation Controls EngineerJob Description The Automation Controls Engineer provides hands-on support for facility and utility control systems within a sterile pharmaceutical manufacturing operation. This role owns or supports the Building Management System (BMS), Environmental Monitoring System (EMS), cleanroom HVAC controls, PLC/HMI/SCADA systems, field instrumentation, and critical utilities including purified water, WFI, clean steam, process gases, compressed air, and chilled water. The engineer maintains validated systems, responds to alarms, drives reliability improvements, and collaborates closely with cross-functional teams to ensure safe, compliant, and reliable operations in a highly controlled environment. Responsibilities • Support, configure, and troubleshoot Building Management Systems and Environmental Monitoring Systems used to control and monitor facility and utility operations., • Own or support the design, configuration, and maintenance of BMS graphics, trends, alarms, schedules, and databases to ensure accurate monitoring and control., • Configure and maintain EMS sensors, monitoring locations, alarm routing, and alarm management strategies to ensure timely and appropriate response to environmental excursions., • Perform system backups and restorations, manage user access, and maintain audit trails in accordance with data integrity and compliance requirements., • Develop, review, and maintain control narratives and sequences of operation, and support historian and reporting functions for critical systems., • Support and troubleshoot cleanroom and HVAC controls, including air-handling units, room pressure cascades, temperature and relative humidity control, airflow and pressure control, and HEPA-related monitoring., • Configure and tune PID loops, and support the operation of variable-frequency drives, dampers, actuators, valves, fans, and coils to maintain stable and compliant environmental conditions., • Respond to alarms and excursions, lead or support cleanroom recovery activities, and provide qualification support for cleanroom and HVAC systems., • Support automation and controls for critical utilities such as purified water, Water for Injection, clean steam, chilled and hot water, compressed air, clean compressed air, process gases, nitrogen, and vacuum., • Assist with utility generation and distribution controls, including sanitization and recirculation sequences, to ensure reliable and compliant utility supply., • Troubleshoot PLCs, HMIs, SCADA systems, field instrumentation, sensors, VFDs, control valves, industrial communications, and control loops in a regulated or highly controlled environment., • Maintain validated control systems and support change controls, investigations, and corrective actions related to automation, utilities, and environmental systems., • Lead or participate in reliability improvement initiatives, focusing on alarm management, system standards, and lifecycle ownership of automation and control systems., • Work closely with Facilities, Utilities, Maintenance, Quality, Validation, Microbiology, Metrology, Sterility Assurance, IT/OT, vendors, and system integrators to coordinate projects, troubleshooting, and system enhancements., • Read and interpret P&IDs, electrical drawings, control schematics, loop diagrams, and sequences of operation to diagnose issues and implement improvements., • Work safely around facility, utility, HVAC, electrical, and process systems, following established safety procedures and best practices., • Support commissioning and qualification activities for new or modified automation and control systems, ensuring compliance with regulatory and internal standards., • Provide on-call, shutdown, weekend, holiday, and off-shift support as needed to respond to emergencies, planned outages, and critical events., • Contribute to cybersecurity and OT network segmentation efforts related to automation systems, servers, and industrial networks., • Act as or develop into a subject-matter expert for critical systems, providing guidance, training, and technical leadership across the operation.Essential Skills, • Bachelors degree in engineering or a related technical discipline, or an equivalent combination of education and directly relevant automation experience., • Approximately five or more years of relevant experience in controls, automation, facilities, utilities, instrumentation, or building systems., • Hands-on experience configuring, maintaining, or troubleshooting a Building Management System or Environmental Monitoring System in a regulated or highly controlled facility., • Demonstrated experience supporting automation and controls for cleanroom HVAC, air-handling units, room pressure cascades, temperature and humidity control, or critical facility utilities., • Strong hands-on ability to troubleshoot PLCs, HMIs, SCADA systems, field instrumentation, sensors, variable-frequency drives, control valves, industrial communications, and control loops., • Proficiency with Building Management Systems, Environmental Monitoring Systems, cleanroom HVAC controls, and critical utility systems such as purified water, WFI, and clean steam., • Ability to troubleshoot controllers, servers, networks, sensors, VFDs, valves, and other field devices in an operational environment., • Ability to read and interpret P&IDs, electrical drawings, control schematics, loop diagrams, and sequences of operation., • Experience working safely around facility, utility, HVAC, electrical, or process systems, with a strong focus on safety and compliance., • Comfort working in cleanrooms, mechanical rooms, utility areas, and other facility spaces in an on-site, hands-on capacity.Additional Skills & Qualifications, • Experience in pharmaceutical, biotechnology, medical device, semiconductor, food, or other controlled manufacturing environments., • GMP experience with Building Management Systems or Environmental Monitoring Systems, including operation in Grade A, B, C, or D cleanrooms., • Experience with controls for purified water, Water for Injection, and clean steam systems., • Exposure to FDA-regulated computerized systems and knowledge of 21 CFR Part 11 requirements., • Commissioning and qualification experience for automation, HVAC, or utility control systems., • Exposure to OT cybersecurity practices and network segmentation for industrial control systems., • Experience with sterile fill-finish, biologics, parenteral operations, isolators, RABS, or 503B environments., • Interest in high-impact facilities automation roles with broad ownership across BMS, EMS, HVAC, and utilities., • Desire to work in a hands-on, technically diverse position with exposure to controls, instrumentation, networks, servers, and cybersecurity., • Motivation to grow into a critical system subject-matter expert and advance as the operation and engineering organization develops.Work Environment This role is based in a GMP sterile pharmaceutical manufacturing facility that includes cleanrooms and controlled environments, Grade A, B, C, and D classified areas, controlled non-classified support spaces, laboratories, manufacturing suites, mechanical and utility rooms, electrical and automation spaces, interstitial areas, roofs, and warehouses. Work involves regular presence in cleanrooms, mechanical rooms, utility areas, and other facility spaces, with exposure to pressurized utilities, steam, chemicals, disinfectants, energized systems, rotating equipment, and automated machinery. Strict adherence to safety, contamination control, lockout/tagout, electrical safety, GMP, documentation, cybersecurity, and data integrity procedures is required. Cleanroom gowning and appropriate PPE are required when entering classified areas. The role may involve carrying laptops, diagnostic equipment, tools, or components up to approximately 25 pounds. Occasional overtime, shutdown support, weekend and holiday coverage, and emergency response are part of the work environment, reflecting the critical nature of the facilitys operations. Job Type & Location This is a Permanent position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $135000.00 - $160000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Company offers medical, dental and vision Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on Oct 14, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

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This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. • Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation., • Complete all assignments in a professional and timely manner in accordance with Company and Client business rules., • Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS)., • Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels., • Ensure that assignments are scheduled in accordance within Client expectations and timelines, • Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: • Ability to utilize smartphone to update AIMS and complete assignments., • Follow all department and company policies and procedures., • Strive to exceed client needs., • Communicate clearly and professionally in email and phone calls. Minimum Job Requirements: • High School Diploma or GED Required, • College Degree Preferred, • Must have mobile electronic device., • Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: • Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: • May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The actual compensation for the position may vary based on market differences and on factors such as skills, experience, qualifications and can vary based on location and/or work schedule. In addition to base pay, CareTria offers a comprehensive benefits package. Full-Time benefits include access to health, dental, and vision insurance; retirement plan options; paid time off; paid parental leave; employee assistance programs; and other perks. Eligible employees may also have access to performance bonuses. CareTria is an Equal Opportunity Employer.

Customer Support Representative 503BANivagen 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.At Nivagen, the Customer Support Representative is responsible for office customer service, warehouse operations, and packing and shipping products. This role is at the heart of our customer interactions, where empathy, efficiency, and expertise converge to provide an unparalleled experience. As the voice of Nivagen, you will respond to and assist customers with a professional, friendly, and prompt demeanor.Responsibilities:Serve as the primary contact for customer inquiries regarding products, orders, pricing, availability, shipping, and account management.Process and monitor customer orders accurately and efficiently through internal systems.Coordinate with Operations, Quality Assurance, Production, Regulatory Affairs, and Logistics teams to resolve customer issues and provide timely updates.Maintain detailed and accurate customer records, communications, and order documentation.Communicate product availability, lead times, shortages, backorders, and shipment status to customers.Investigate and resolve customer complaints, discrepancies, and service-related issues while maintaining a high level of professionalism.Support onboarding of new customer accounts and assist with account setup documentation.Ensure all customer interactions comply with FDA regulations, company policies, and applicable quality standards.Escalate quality events, adverse event reports, product complaints, and compliance concerns according to established procedures.Assist with customer surveys, reporting, and continuous improvement initiatives.Contribute to the development of customer service processes and standard operating procedures (SOPs) as the organization grows.Maintain a thorough understanding of company products, services, and regulatory requirements.Qualifications:Education/Experience:Bachelor's degree preferred.Experience in pharmaceutical, healthcare, biotechnology, medical device, or regulated manufacturing environments.Knowledge of 503B outsourcing for hospitals and/or wellness, sterile compounding, injectables or FDA-regulated operations.Experience supporting hospitals, clinics, healthcare systems, surgery centers, or healthcare providers.Knowledge, Skills, and Abilities:Crafts and delivers clear communications tailored to the unique needs of various audiencesHolds self and others responsible for meeting commitmentsIdentifies and implements the most effective and efficient methods to complete tasks, focusing on continuous improvementAnalyzes complex and sometimes contradictory information to solve problems effectivelyFlexible to assist other departments as needed, with appropriate training providedBuilds strong customer relationships and delivers customer-centric solutionsAdjusts approach and demeanor in real-time to meet the shifting demands of different situationsAbility to work in a fast-paced and changing environmentUnderstanding and experience in customer service and supply chainsPull supplies for the order and keep track of the inventory systemExperience in warehouse management, inventory preferredFamiliar with Bookkeeping and accountingExperience with QuickBooks is a plusStrong interpersonal and de-escalation skillsProficient in Microsoft OfficeBuilds partnerships and works collaboratively with others to achieve shared goalsEffectively secures and deploys resourcesRequirements:2+ years of customer service, account support, or order management experience.Strong communication, problem-solving, and interpersonal skills.Excellent organizational skills with strong attention to detail.Proficiency with Microsoft Office Suite and CRM/SAP systems.Ability to manage multiple priorities in a fast-paced startup environment.Professional demeanor and commitment to delivering exceptional customer service.Work in controlled environments and wear personal protective equipment, as necessaryValid driver's license and acceptable driving recordLegally authorized to be employed in the United States (U.S. citizens or national, permanent residents)Benefits:Fulltime$30.07 to $31.47 per hour based upon experienceYearly bonus eligibilityBenefits: Nivagen offers a wide variety of benefits and programs to support health and well-beingMedical, dental and vision coveragePaid time off plan401k savings planNivagen 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.

Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose.If you want to make a difference at the center of health, come join our innovative company

Microbiology Lab Associate (Onsite, 30 hrs/week to start ? FT) — FDA cGMP Contract Testing | South Plainfield, NJ | $55,000–$70,000 (FT equivalent) | Start ASAP | Must be US-work authorized & local This Jobot Job is hosted by: Andrew Kraig Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $55,000 - $70,000 per year A bit about us: Founded over a decade ago and based in South Plainfield, we are an FDA cGMP contract laboratory providing microbiological testing for pharmaceutical, OTC, cosmetic, dietary supplement, and botanical products. We partner closely with client QA/RA teams to deliver compliant, on-time results with rigorous data integrity and responsive service. Why join us? • Competitive Compensation: Up to $70,000 base salary (DOE) equivalent for FT, with immediate part-time schedule (~30 hrs/week) and path to full-time, • 401(k) with potential match (company plan details to be shared), • Comprehensive Benefits: Medical, Dental, Vision (FT conversion), • Generous PTO & Paid Holidays (FT conversion), • Collaborative Work Environment: Work cross-functionally with Chemistry, QA, and Micro teams; hands-on impact in a growing lab, • Work-Life Balance: Predictable daytime schedule with occasional weekend/evening work as needed, • 100% Onsite: Modern lab environment; learn end-to-end cGMP testing workflows Job Details Key Responsibilities and Duties: • Perform routine microbiology testing: microbial limit tests (USP <61>/<62>), method suitability, preservative efficacy (AET/PET), microbial ID, water testing, and bioburden monitoring, • Read, record, and analyze results in accordance with FDA cGMP and GDP standards; ensure data integrity and traceability, • Conduct peer review of data for accuracy and protocol compliance, • Maintain cultures; prepare media and perform growth promotion testing, • Manage day-to-day lab operations including inventory of media/supplies; clean and maintain equipment (incubators, refrigerators, freezers), • Support method development and validation activities as needed, • Independently plan and manage daily workload to meet client timelines, • Adhere to all company policies, SOPs, and safety requirements You should have most of the following: • Bachelor’s degree in a scientific discipline (Microbiology or Biological Sciences preferred), • Minimum 2–3 years of relevant microbiology lab experience in a regulated/GMP setting, • Demonstrated proficiency with aseptic technique, • Hands-on experience with USP <61>/<62> microbial limit testing (or closely related compendial methods), • Familiarity with FDA cGMP and Quality procedures; strong GDP documentation habits, • Ability to organize and maintain complete, compliant project records; deliver accurate, on-time results, • Team-oriented, reliable, and able to work occasional weekends/evenings, • Must be currently authorized to work in the US; local to South Plainfield, NJ; 100% onsite Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy