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Job DescriptionAbout the Client Our client is a pharmaceutical manufacturing company operating in a regulated, cGMP-compliant environment, focused on quality, safety, and operational efficiency. The organization supports high-volume production and packaging operations, maintaining strict standards across all manufacturing processes. Role Overview: The Packaging Mechanic II is responsible for operating, repairing, and maintaining packaging equipment in a pharmaceutical manufacturing environment. This role, working under limited supervision, supports equipment reliability, production efficiency, and continuous improvement across packaging lines. This is a hands-on, mid-level technical role requiring experience with packaging machinery, changeovers, preventive maintenance, and troubleshooting, with the ability to work more independently while ensuring compliance with cGMP, safety, and environmental standards. This role requires flexibility to work across all shifts (1st, 2nd, and 3rd) and to work overtime, extended hours, or weekends as needed to support production demands. . Job Requirements: • High school diploma or GED required., • 3–5 years of experience in the repair and maintenance of packaging equipment or industrial machinery, or equivalent combination of education and experience., • Strong mechanical aptitude with the ability to troubleshoot and repair equipment independently., • Knowledge of lockout/tagout (LOTO) procedures and compliance with EHS regulations., • Ability to read and interpret technical diagrams, gauges, maps, tables, and instrumentation., • Strong problem-solving and analytical skills., • Ability to effectively communicate in one-on-one and small group settings., • Solid math skills, including basic operations, ratios, percentages, and unit conversions., • Ability to work in a fast-paced manufacturing environment., • Working knowledge or exposure to PLC systems (Programmable Logic Controls) and ladder logic., • Technical school certification or related training., • 3–5 years of mechanical and electrical experience in a packaging or manufacturing environment., • Exposure to moving mechanical parts and vibration in a manufacturing environment., • Frequent standing (up to 8 hours), walking, bending, kneeling, crouching, crawling, and climbing., • Ability to lift and move items over 50 lbs., • Ability to perform tasks requiring close vision, distance vision, color vision, peripheral vision, and depth perception., • Repair Packaging Equipment: Perform repairs on packaging machinery as needed to maintain uptime., • Perform Preventive Maintenance: Conduct routine and preventive maintenance to eliminate unscheduled downtime., • Execute Changeovers: Independently perform equipment changeovers to meet production requirements., • Ensure Compliance: Perform all work in accordance with cGMP, safety practices, housekeeping standards, and environmental regulations., • Support Team Collaboration: Participate in team processes and maintain strong relationships with customers, suppliers, and internal teams., • Manage Tools & Parts: Initiate the purchase of required tools, parts, and materials, and maintain accountability for issued items., • Develop Technical Skills: Continuously upgrade skills as equipment and technology evolve., • Demonstrate Workmanship: Maintain a high level of quality craftsmanship and ownership., • Report Equipment Issues: Notify the Supervisor of breakdowns that require 20 minutes or more to repair., • Work with PLC Systems: Develop familiarity and working knowledge of PLC systems and ladder logic., • Promote Safety: Report health and safety hazards and support corrective actions., • New hires or internal transfers will complete a three-month training and orientation period. We celebrate diversity and are committed to creating an inclusive environment for all employees and applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. If you require a reasonable accommodation during the application or interview process, please contact us at so we can assist you.

Job DescriptionAbout the Client Our client is a pharmaceutical manufacturing company operating in a regulated, cGMP-compliant environment, focused on quality, safety, and operational efficiency. The organization supports high-volume production and packaging operations, maintaining strict standards across all manufacturing processes. Role Overview: The Packaging Mechanic is responsible for the operation, maintenance, and repair of packaging equipment within a pharmaceutical manufacturing environment. This is a hands-on role focused on ensuring equipment reliability, minimizing downtime, and supporting efficient production operations. Under limited supervision, this position performs preventive maintenance, equipment troubleshooting, and changeovers while ensuring compliance with cGMP, safety, and environmental standards. The ideal candidate has strong mechanical aptitude, experience working with packaging machinery, and thrives in a fast-paced production environment. This role requires flexibility to work across all shifts (1st, 2nd, and 3rd) and to work overtime, extended hours, or weekends as needed to support production demands. Job Requirements: • High school diploma or GED required., • 3–5 years of experience in the repair and maintenance of packaging equipment or industrial machinery, or equivalent combination of education and experience., • Strong mechanical aptitude with the ability to troubleshoot and resolve equipment issues., • Knowledge of lockout/tagout (LOTO) procedures and workplace safety practices., • Ability to read and interpret technical diagrams, gauges, tables, and equipment documentation., • Basic math skills including addition, subtraction, multiplication, and division., • Ability to work in a fast-paced manufacturing environment.Preferred Qualifications:, • Technical school certification or related training., • Experience with mechanical and electrical systems in a packaging or manufacturing environment., • Familiarity with machine shop equipment and tools.Key Responsibilities:, • Perform Preventive Maintenance: Conduct routine and preventive maintenance on packaging equipment to minimize downtime., • Support Equipment Changeovers: Assist with line changeovers and equipment adjustments to support production needs., • Troubleshoot & Repair Equipment: Diagnose and repair mechanical issues affecting packaging operations., • Ensure cGMP Compliance: Perform all work in accordance with cGMP standards, safety practices, and environmental regulations., • Maintain Equipment Performance: Notify supervisors of breakdowns lasting more than 20 minutes and support timely resolution., • Promote Safety Standards: Identify and report health and safety hazards and support corrective actions., • Maintain Work Standards: Demonstrate commitment to quality workmanship, accountability, and job ownership., • Support Production Operations: Collaborate with supervisors and team members to ensure efficient production flow. We celebrate diversity and are committed to creating an inclusive environment for all employees and applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. If you require a reasonable accommodation during the application or interview process, please contact us at so we can assist you.

Position: Manufacturing Supervisor Department: Operations Reports to: VP of Operations & Quality Position Summary: The Manufacturing Supervisor is responsible for overseeing daily manufacturing operations to ensure production activities are completed safely, efficiently, and in compliance with company procedures and regulatory requirements. This role supervises manufacturing staff, coordinates production schedules, and works cross-functionally with Packaging, Engineering, and Quality to ensure consistent product output for gel-based medical device and OTC products. Key Responsibilities • Supervise and direct manufacturing staff to ensure production activities are completed on schedule and according to company policies and procedures., • Ensure the manufacturing team adheres to company SOPs, safety regulations, and regulatory requirements including FDA, cGMP, ISO 13485, MDD, and CMDR standards., • Coordinate production runs with the Packaging Department to ensure proper materials are available and production schedules are maintained., • Oversee the efficient and accurate manufacturing of core products, imprints, and special orders., • Participate in weekly production planning meetings and provide updates on manufacturing status and challenges., • Monitor production performance and prepare production reports as required, including adherence to the weekly production schedule., • Work with Engineering to support modifications, troubleshooting, and improvements to processing equipment and manufacturing processes., • Ensure manufacturing documentation is completed accurately and in accordance with quality system requirements., • Maintain a safe, clean, and organized production environment., • Support training of manufacturing staff and participate in internal training initiatives., • Complete special projects and operational initiatives as assigned by management. Skills & Competencies • Strong leadership and supervisory skills with the ability to motivate and guide teams, • Excellent interpersonal and communication skills, • Ability to enforce policies and procedures while maintaining positive team relationships, • Strong organizational and problem-solving abilities, • Detail-oriented with a strong focus on quality and compliance, • Ability to manage multiple priorities in a fast-paced manufacturing environment, • Team-oriented with strong collaboration skills, • Proficiency in Microsoft Office applications Qualifications • Minimum of 3 years of supervisory experience in a manufacturing environment, • Experience working in regulated manufacturing environments (medical device, pharmaceutical, cosmetics, or similar industries preferred), • Bachelor’s degree in a technical or engineering-related field preferred, • Knowledge of cGMP, FDA regulations, and ISO 13485 standards preferred, • Experience with production scheduling and manufacturing reporting Work Environment • This role operates primarily in a manufacturing environment and requires regular interaction with production and packaging personnel, engineering staff, and quality teams.

Who We Are: Eastern Controls is a family-owned manufacturer’s representative located in the suburbs of Philadelphia, PA that provides the best-in-class process control solutions, service and training. We collaborate with customers in the Life Sciences, Power, Water & Wastewater, Chemical, Refinery, Food & Beverage, and other process-centered industries across an expanding map of geographies. We’re expanding rapidly, technically challenging, and pride ourselves on providing an unrivalled customer experience. If you enjoy a fun, fast-paced company that directly impacts life-sustaining industries and the industrial infrastructure of the United States, apply today. Who We’re Seeking: People would describe you as passionate, driven, energetic, AND technically minded. Must have a strong work ethic, coupled with the ability to influence others, drive sales and serve as the trusted advisor to your customers to solve their biggest engineering challenges. We’re seeking a “hunter” who can grow their given territory significantly while maintaining great relationships with customers and the manufacturers we represent. Strong technical communications skills and organization are critical; you can explain how something works, how it will solve a problem and/or work within a manufacturing process. Managing your schedule, book of business, calls and emails from customers is second nature to you. You love being in front of the customer and aren’t afraid to go the extra mile to get your foot in the door, hand-deliver an order, or help in a pinch. Education: Bachelor’s degree in business/engineering/ or technical degree preferred. Industrial automation or process industry experience preferred. We sell, service and support process control products to engineers/technicians in industrial applications; technical sales experience, analytical aptitude and curiosity are essential to the role. Experience: While we are open to a new/recent graduate who could be trained, we prefer someone who has a passion for process applications within industries of power, oil/gas, chemical, water / wastewater treatment, food & beverage production, pharmaceutical, pulp & paper, and other life-sustaining manufacturing facilities. Candidates must possess an enthusiasm for the types of products we sell and service (process measurement instrumentation, controls valves, actuators, positioners, gas & flame detection and electrical heat trace) and show clear evidence of personal success in growing/building a business (or similar endeavor). Requirements Cultural Fit: Family founded and owned since 1969, Eastern Controls is rooted in strong relationships, technical expertise, and a positive mindset. We work hard, have fun, and treat one another with respect and kindness. Our growth goals aim to serve the myriad of life-sustaining applications we touch, the dedicated customers and manufacturers we partner with, and the employees we call family. Area of Coverage: Northern New Jersey Location: Ideal candidate will live in the sales territory Northern/Central New Jersey, or Eastern PA (I-78/I-80 Access) Travel / Office: Candidate would work out of their home office with local travel to existing customers and building relationships with new customers throughout the territory. Occasional overnight travel required for training and meetings. Initially would need to spend significant time at our headquarters in Edgemont, PA (southwest of Philadelphia) for training and immersion on the product lines. Typically visit the ECI office as needed for additional sales meetings / training. Position Start Date: Immediately Job Category: Sales Job Type: Full Time Job Location: Remote within sales territory (HQ, + designated sales territory) Eastern Controls is dedicated to the principles of equal employment opportunity. We prohibit unlawful discrimination against applicants or employees on the basis of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.

Job Locations US ID 2026-1934 Category Medical Affairs Type Regular Full-Time Working closely with the Early Development Lead, the Senior/Executive Director of Clinical Development Oncology will lead clinical execution of targeted protein degradation (TPD) projects for SK Life Science Labs (SKLSL) with a dotted line into its sister company, SK Life Science Inc. (SKLSI). This role will provide strategic leadership across both preclinical and clinical development, ensuring seamless translation of discovery and preclinical findings into early- and late-stage clinical programs, with a particular focus on oncology. The incumbent will provide therapeutic and translational expertise to the development of the current TPD asset(s), while also contributing to portfolio and pipeline strategy. The role includes close partnership with discovery, preclinical, translational, CMC, regulatory, and clinical operations teams to enable efficient progression from IND-enabling activities through clinical proof-of-concept. The position reports to the Chief Scientific Officer of SK Life Science Labs with a dotted line to the Chief Medical Officer of SK Life Science Inc. Preclinical and Translational Development Provide clinical and translational leadership to preclinical oncology programs • Partner closely with discovery and preclinical teams to ensure alignment between biological rationale, nonclinical data packages, and clinical development plans, • Contribute to the design, interpretation, and integration of:, • In vitro and in vivo efficacy models, • PK/PD and biomarker strategies, • Translational endpoints to support dose selection and first-in-human studies, • Provide medical and scientific input into IND-enabling studies, including toxicology, safety pharmacology, and reproductive toxicology, • Support development of translational and biomarker strategies to enable early signal detection and patient selection in oncology trials, • Participate in the development of integrated product development plans and clinical trial strategies informed by preclinical and translational data, • Lead the design and conduct of clinical trials and, as a member of the internal SK Life Science Inc. Clinical Development/Medical Affairs team, provide operational oversight by collaborating with internal and external operations personnel, • Provide medical expertise regarding product development or other scientific issues for drug discovery, development, and senior management decision-making, • Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials, • Participate in pharmacovigilance activities, including SAE evaluation, safety signal assessment, and ongoing analysis of safety data, • Participate in preparation and review of protocols, Investigator Brochures, clinical study reports, safety reports, and clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts, • Interface with regulatory agencies for clinical development programs and regulatory submissions as needed, • Oversee scientific interactions with medical consultants, advisors, and clinical investigators, • Training in and adherence to Good Clinical Practices (GCP); working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as they relate to preclinical and clinical development, • Knowledge of relevant global regulatory guidance impacting preclinical, translational, and clinical development, • Experience interacting with FDA and other global health authorities preferred, • Evidence of ability to work with opinion leaders, • Must be able to work effectively in a team setting, • Communication skills necessary to:, • Represent the Company externally in scientific presentations, conferences and industry groups;, • Present to internal stakeholders; Interact with industry, • M.D. degree with specialized training in oncology preferred, • Practice experience preferable but not required, • Minimum of 10 years of experience in clinical development in the pharmaceutical industry, preferably with oncology compounds or relevant academic research experience, • Ability to multitask, • Adapts to change, • Maintain composure under pressure, • Ability to follow verbal or written instructions and use of effective verbal communications, • Adapts change, adjust change and grasps information quickly, • Examine and observe details

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. JOB SUMMARY: The Associate Director, Americas Network Lead will be responsible for endtoend leadership of network infrastructure operations across all sites in the Americas region. This will include ownership of Eisai's hybrid network ecosystem, encompassing SDWAN, campus/LAN networks, wireless, cloud connectivity, remote access solutions, Zscaler (ZIA/ZPA), global firewall standards, DNS/DHCP/IPAM, IDS/IPS, NAC, NDR and secure internet egress infrastructure. Reporting to the Americas Infrastructure Lead & Global Network Lead, this role will ensure high availability, reliability, and optimization of the network and adjacent infrastructure components that support businesscritical operations. The individual will collaborate with U.S. Regional Leads, Global Functional Lead, Global Infrastructure teams, IT Security, and site leadership to align operations with defined network standards, global architectures, Zero Trust principles, and compliance frameworks. The role will include oversight of onsite infrastructure resources, network vendors, and managed service partners, with a focus on operational excellence, security, and business continuity. ESSENTIAL FUNCTIONS: Infrastructure & Network Operations Leadership • Lead daytoday operations of Eisai's Americas network environment, including SDWAN architecture, LAN/WAN, WiFi, remote access, Zscaler ZIA/ZPA, and AWS cloud network connectivity (VPCs, Transit Gateway, routing, and segmentation)., • Ensure high availability, reliability, and performance of critical network services supporting research, manufacturing, labs, corporate offices, commercial operations, and cloud workloads., • Oversee incident, problem, and request management for all networkrelated issues, ensuring rapid remediation and adherence to SLA expectations., • Implement proactive monitoring, telemetry, and performance optimization using tools such as ThousandEyes, SolarWinds, Zscaler analytics, and CloudWatch., • Maintain standardized network configurations, ensuring adherence to global network architecture, Zero Trust, segmentation, and firewall policies., • Lead annual and multiyear regional network budget planning, ensuring forecasting accuracy and financial alignment to strategic priorities., • Manage ongoing operational spend, licensing, carrier contracts, and cloud networking costs to ensure financial stewardship across the Americas region. Service Desk & Technical Support Oversight • Partner with the service desk and site support teams to streamline escalation paths for network issues and maintain clear troubleshooting runbooks., • Create necessary KB documents to enable IT Service Desk team., • Ensure frontline and L2 staff are equipped with accurate triage documentation and diagnostic guidelines related to network operations., • Define and track KPIs tied to network reliability, incident response, service availability, and user experience., • Drive continuous improvement initiatives and reduce repetitive incidents through root cause analysis. Vendor & Partner Management • Manage strategic vendor relationships, including network carriers, SDWAN providers, Zscaler, firewall partners, monitoring vendors, and managed network services partners., • Oversee SLA adherence, change management, and operational performance across all thirdparty network support agreements., • Conduct and lead quarterly business reviews (QBRs) with all strategic vendors, • Collaborate with procurement and U.S. regional teams for contract renewals, licensing, bandwidth provisioning, and new network service onboarding., • Evaluate technology upgrades, roadmap alignment, and cost optimization opportunities. Backup, Recovery & Business Continuity • Ensure connectivity resilience through redundant WAN paths, HA firewall clusters, diverse internet egress, and cloud failover mechanisms., • Maintain and validate networkspecific DR procedures including SDWAN failover, DNS/DHCP/IPAM recovery, and cloud routing restoration., • Coordinate with global teams to align network DR strategies with enterprise business continuity plans. Collaboration & Communication • Serve as the primary liaison between site operations, global network engineering, cloud networking teams, and IT Security., • Communicate network performance, risks, planned maintenance, and major incidents to regional leadership and stakeholders., • Represent Americas views in global architecture discussions related to Zero Trust, segmentation, cloud expansion, cyber controls, and service reliability., • Plan, coordinate, and execute regional network projects including SDWAN upgrades, Zscaler policy rollouts, firewall refresh cycles, wireless modernization, cloud connectivity expansions, and site readiness for business initiatives., • Ensure network projects are delivered on time, within budget, and aligned to global architectural standards. Infrastructure Security & Compliance • Maintain a strong network security posture through strict adherence to Zscaler policies, firewall standards, segmentation rules, and Zero Trust requirements., • Partner with the Security team to analyze vulnerabilities, implement controls, enforce leastprivilege access, and support incident investigations., • Ensure compliance with audit requirements, GxP guidelines, regulatory expectations, and enterprise security frameworks., • Implement logging, alerting, and monitoring across critical systems. Leadership & Team Management • Mentor regional infrastructure personnel, including network engineers and site support teams., • Support workforce planning and develop technical capability roadmaps for the team., • Develop technical capability across the team through skill development, crosstraining, and knowledgesharing., • Foster a culture of ownership, operational discipline, customer focus, and continuous improvement. REQUIREMENTS: Mandatory Experience Requirements: • Bachelor's degree in IT, Computer Science, or related discipline., • The candidate must have a minimum of 10+ years of experience leading network engineering and operations teams in a complex, multisite enterprise environment, • Deep expertise in SDWAN, LAN/WAN, WiFi, firewalls, DNS/DHCP/IPAM, cloud networking, and hybrid network design., • Requires deep, practical experience with cloud networking in AWS and Azure, including VPC/VNet design, routing, security controls, and hybrid connectivity models., • Experience with Zscaler ZIA/ZPA, Zero Trust access models, and secure internet egress architectures., • Strong understanding of network security, segmentation, identitybased access controls, and cybersecurity integration., • Proven ability to lead technical teams and manage vendor partnerships., • Strong troubleshooting, stakeholder communication, and operational leadership skills., • Familiarity with regulated environments and audit requirements., • Able to work hybrid in our Nutley, NJ office (Tuesday, Wednesday, Thursday in office every week). Nice-to-Have Skills/Experience • Experience in pharmaceutical, biotech, manufacturing, or other regulated sectors., • Experience managing MSP-driven operating models., • Familiarity with Fortinet, Cisco, Aruba, AWS/Azure networking tools, Zscaler, and enterprise monitoring solutions., • ITIL certification or experience with ITIL-based processes., • Project management or leadership training certifications. Success Criteria: • Deliver reliable, stable network services across all Americas sites., • Ensure strong vendor/partner performance with consistent SLA/KPI compliance., • Maintain predictable budgeting and costefficient network operations., • Align regional network operations with global architecture and Zero Trust standards., • Reduce networkrelated incidents and enhance overall user experience., • Strengthen support capabilities for Network services across L1-L3 teams with clear processes and documentation., • Represent Americas needs effectively in global planning and ensure alignment with global strategy., • Ensure strict adherence to security, audit, and regulatory compliance requirements across all network services. #MI-LI1 Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Americas Network Lead is from :$173,100-$227,200 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Job Locations US-NJ-Paramus ID 2026-1944 Category Regulatory Affairs Type Regular Full-Time A Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) Strategy is a leadership role within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality and manufacturing of drug products. Strategic Leadership:Develop and execute global CMC regulatory strategies for products ranging from early-stage clinical development to post-approval lifecycle management. • Regulatory Submissions:Oversee the preparation and high-quality review of CMC components for major filings, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval supplements. Ensure CMC components in regulatory filings are scientifically sound, compliant, and aligned with ICH, FDA, EMA, and other global guidelines., • Health Authority Interactions:Serve as the primary point of contact for CMC-related negotiations with regulatory agencies, including leading formal meetings and responding to deficiency letters., • Cross-Functional Collaboration: Partner with Quality Assurance, CMC and Clinical Supply, R&D to ensure compliance with cGMP (current Good Manufacturing Practices) and assess the regulatory impact of CMC development plans and manufacturing changes., • Intelligence & Compliance:Monitor the evolving global regulatory landscape and communicate the impact of new guidelines (e.g., ICH guidelines) to senior leadership., • May be required to mentor and provide guidance to junior team members., • A bachelor's degree in a scientific field (Chemistry, Pharmacy, Biology, or Engineering) is required; an advanced degree (MS, PhD, or PharmD) is highly preferred., • Requires 10-15+ yearsin the pharmaceutical industry, with at least 8-10 years specifically focused on CMC regulatory affairs, • Deep expertise in eCTDsubmission formats, global regulatory requirements (US, EU, and Canada), and a proven track record of successful marketing application approvals., • Strong negotiation, conflict management, and the ability to influence cross-functional teams without direct authority., • Expertise with multiple dosage forms for small molecule drugs is preferred, • Experience with biologics is a plus., • Ability to travel up to 20% of the time domestically and internationally, • Experience working with Veeva

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Summary: The Manager, Graphics Design is a self-directed contributor responsible for design and development of pharmaceutical product labeling artwork for primary and secondary packaging of pharmaceutical products, package inserts, and trade labeling. These activities support proposed, new, and existing commercial products. This position demonstrates high level performance and delivers high quality labeling artwork design for product packaging on schedule to meet patient, company, and regulatory needs. This position is responsible for development of, and company adherence to, cGMP compliant prescription pharmaceutical labeling artwork control and approval systems and procedures. This position requires continuous collaboration with multiple internal Eisai departments, Global Regulatory Affiliates, and Corporate Alliance Partners to assess labeling artwork needs and provide quality, compliant product labeling artwork for global product distribution. This position is responsible for security and control of Eisai Raleigh managed product labeling artwork files and electronic labeling artwork file systems. This position manages the graphic design contract service providers as needed to support high volume, critical path projects. The Manager, Graphic Design is a self-directed SME for labeling artwork management and control systems. This position determines how best to manage multiple projects and tasks to meet challenging, shifting timelines to support Eisai products packaged and/ or launched at external sites. Extensive industry experience and independent decision making is necessary to define, facilitate and/or customize cGMP compliant pharmaceutical labeling artwork procedures and systems to manage ethical drug product labeling requirements for US and ROW country specific product packaging within project specific labeling formats that involve multiple levels of complexity. Responsible for management of contract service providers (proofreaders and back-up graphic designer ) any additional graphics service providers that may be needed to support trade labeling. The Manager, Graphic Design stays abreast of and conversant in current pharmaceutical labeling artwork trends, requirements, best practices, and new technology relevant to product labeling. Collaborates with other functional groups within the company and maintains membership in industry-related packaging organizations such as IOPP/PmDLC to understand industry trends and best practices. May participate in industry group meetings, forums and cross-company benchmarking efforts. Essential Functions: • Creation, development and control of pharmaceutical labeling artwork for contractor-packaged prescription drug products. Collaborates directly with Supply Operations, Contract Manufacturing Operations (CMOs), multiple external contract packaging sites, country specific Global Regulatory Affiliates, Marketing, Technical Operations, Quality Assurance, and Corporate Alliance Partners to provide high quality, regulatory compliant labeling artwork for commercial products managed by Eisai Raleigh site., • Facilitates communication between cross-functional teams to support end-to-end labeling and timely implementation of regulatory updates., • Provides pharmaceutical product labeling artwork to meet critical path deadlines for new US and ROW product launches and / or submissions to the FDA and other country specific regulatory authorities, to facilitate global product launch initiatives., • Collaborates with Technical Operations during development of new packaging components for launch or line changes and develops test component artwork to support package line initiatives., • Strengthens and maintains cGMP compliant procedures for prescription pharmaceutical labeling artwork control and approval. Collaborates with management of affected departments to ensure cohesive working relationships and to meet shared objectives., • Management of contract service providers for support of labeling artwork procedures & systems to maintain and control current and retired FDA approved labeling artwork files., • Management of contract design services as needed to support high volume critical path projects. Requirements: • Bachelor's degree in graphic design, • 1-year related work experience in the pharmaceutical industry., • High skill level and understanding of design programs on Macintosh platform. Direct experience with Adobe Creative Cloud required., • Knowledge and experience with labeling security and serialization features., • Understanding of and direct experience with cGMP and FDA Regulatory prescription pharmaceutical labeling requirements., • Understanding of and direct experience with ROW, Canada, and emerging market country-specific labeling artwork requirements., • Ability to work independently and effectively, prioritizing assignments without supervision., • Highly developed interpersonal skills are required to effectively deal with all levels of personnel from executives to non-exempt and outside vendors., • Ability to exercise independent judgment and initiative on labeling matters., • Demonstrated initiative, results oriented, willingness and ability to institute change., • Process oriented with a strong interest in continuous improvement. #LI-MI1 Eisai Salary Transparency Language: The annual base salary range for the Manager, Graphics Design - Remote is from :$102,300-$134,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles. We are looking for our next Process Engineer II or III within our Operations Team. The Process Engineer will be responsible for supporting day-to-day support of production processes and developing and implementing improvements to existing processes and products in order to meet corporate and customer standards. This position is located in Newark, Delaware. Compensation: The current salary range for this role is estimated to be $85,000 - $125,000. In addition, this position will be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location. What You'll Do: • Serve as the SME and own one or two MCC or non-MCC processing lines, with ability to provide basic or full level support on other lines., • Provide full support and lead or assist in troubleshooting of packaging systems., • Troubleshoot process problems in operations., • Identify and develop process changes and modifications to enhance operating reliability and product quality and to improve efficiencies of key resources., • Identify and develop control mechanisms to improve reliability and efficiency of plant operations., • Understand and track key performance indicators for the manufacturing process, including process yields, rates, etc., • Develop engineering solutions for chronic and sporadic process problems and collaborate with technical, operations, and maintenance to implement solutions., • Identify continuous improvement opportunities and lead implementation of continuous improvement projects., • Undertake cross-training activities to gain understanding of all the processes., • Commission installations in a timely and effective manner., • Write operating procedures and train operators on start-ups and integration of new systems., • Monitor environmental regulations and performance against such as it pertains to project areas., • Independently lead in Root Cause Failure Analysis (RCFA) pertaining to deviations, incident investigations, complaints, etc., • Participate in hazardous operations reviews and project safety reviews and support the plant's safety, health & wellness environmental and industrial hygiene programs. Initiate and drive and execute process changes, new processes and equipment, etc., • Adhere to all GMP standards, specifically regarding documentation., • Operating Services Agreement Activities (Services provided 3rd party owner of one production line), • Coordinate operations activities between Roquette and third-party owner, • Maintain communications for operations issues, changes, etc. between Roquette and third-party owner, • Facilitate process improvements for third-party process and assets, • Provide technical support for third-party process, • Provide daily technical oversight and guidance for colloidal manufacturing process, • Proactively network with other Engineering technical disciplines (e.g., Consultants for Materials, Engineering Mechanics, Instruments & Process Controls, Electrical and Energy), plant and business personnel, and suppliers and contractors to improve process reliability, quality, and safety., • Train peers on relevant operational engineering topics. What You'll Need: Education: • 3-8+ years of experience in manufacturing operations, or equivalent experience., • Experience in food/pharma manufacturing operations preferred., • Excellent computer aptitude, communication and interpersonal skills., • Self-directed and self-motivated., • Solid written and oral communication skills., • Ability to work as a team member in a respectful manner in a diverse work environment., • Strong analytical skills with demonstrated ability to consistently solve problems in a decisive and efficient manner., • Demonstrates understanding of statistical analysis to be used for process improvement., • Demonstrates ability to lead root cause analyses and implement corrective actions to prevent recurrence., • Demonstrates understanding of quality control procedures,, • Demonstrates expertise in processing equipment and plant utilities, or equivalent experience at a manufacturing plant., • Interpersonal skills for working in teams across functions., • Experience using and understanding of Enterprise Resource Planning (ERP) and software systems such as SAP, FMEA+, database/SQL infrastructures, and document control a plus., • Travel, some internationally, may be required when collaborating with other manufacturing facilities, for training, etc. AAP/EEO Statement Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. "AAP, EEO, Drug-Free Workplace" Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. If you identify yourself in this position, please apply byuploading your resume and let's start the journey together! Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences. Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws. As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach. To find out more about our products, values and sustainable development ambitions visit us at ___ and at ___

Job Description About the Company LTS Lohmann Therapy Systems is a global leader in transdermal and oral thin‑film drug delivery technologies. Our teams have pioneered breakthroughs such as the first contraceptive patch, nicotine patch, oral active ingredient film, and Parkinson’s patch. When you join LTS, you become part of a team that continues to shape the future of patient care and bring life‑changing therapies to market. At LTS, our purpose drives everything we do: We CARE. We CREATE. We DELIVER. We’re committed to fostering an employee experience that reflects our innovation — supportive, collaborative, and empowering. Across our New Jersey and Minnesota locations, you’ll work alongside knowledgeable experts on diverse projects in an environment where every day is different and your contributions truly matter Job Summary LTS is seeking a talented Director of Production Management to lead and optimize our Converting and Packaging manufacturing operations. This role plays a critical part in ensuring operational excellence, regulatory compliance, safety, quality, and efficiency within our production environment. The Director will oversee managers and senior supervisors, drive both short‑term performance and long‑term strategy, and partner closely with Operations, Quality, and Engineering teams to deliver high‑quality products that meet our customers’ expectations. This is a full time, onsite role located in West Caldwell, NJ What You Will Do: • Lead and develop managers and senior supervisors across Packaging and Converting operations., • Ensure all activities comply with cGMP, FDA, and DEA regulations., • Drive daily production performance, including scheduling, resource allocation, problem‑solving, and on‑time delivery., • Champion safety initiatives and quality programs to maintain a safe, compliant workplace., • Optimize production efficiency and cost‑effectiveness while meeting regulatory and customer requirements., • Collaborate with the Director of Manufacturing on labor planning and resource utilization., • Support development and oversight of cost control reports, manpower plans, and operating budgets., • Achieve financial objectives through effective planning, monitoring, and forecasting., • Coordinate cross‑functional support to ensure smooth workflow and operational alignment., • Partner with the VP of Operations to deploy Optimization and Reliability Engineers to improve quality and efficiency., • Enhance customer satisfaction by reducing delinquencies and improving delivery performance., • Build strong customer relationships through proactive communication and support., • Lead integration of new technologies and systems across Production, Operations, Quality, and Engineering., • Bachelor’s degree in Process Engineering or a related field., • 10–14 years of pharmaceutical industry experience., • Strong understanding of cGMPs, SOPs, and FDA/DEA regulations., • At least 3 years previous management and leadership experience in a manufacturing environment., • Excellent communication, analytical, and problem‑solving skills., • Proficiency in Microsoft Word, Excel, and PowerPoint., • Experience in packaging and converting environments, • SAP S4HANA experience helpful If this sounds like you, we want to hear from you! LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Locations US-NJ-Paramus ID 2026-1957 Category CMC Type Intern We are seeking a highly motivated Summer Intern to join our CMC (Chemistry, Manufacturing and Controls) and Clinical Supply Team. This internship provides a unique opportunity to gain hands-on experience in pharmaceutical development and supply chain operations supporting clinical programs. The intern will work closely with cross-functional teams involved in drug product manufacturing, labeling, packaging, and clinical supply operations. The primary objective of this role is to evaluate operational performance across several drug products and help identify opportunities to streamline processes, improve efficiency, and enhance supply reliability for clinical studies. This position is ideal for students interested in careers in pharmaceutical development, manufacturing sciences, or technical operations. The intern, in collaboration with SKLSI team members, will develop goals at the beginning of the internship. The intern will take on an active support role and should be comfortable asking questions and taking initiative in order to best enhance their contributions to SKLSI and their own educational experience. Assignment of responsibilities will be commensurate with demonstrated abilities, and, where possible, will be aligned with the intern's goals. This is a paid internship located at the Paramus, NJ facility. Evaluate operational performance of drug product manufacturing, labeling, and packaging activities for multiple clinical-stage products. • Analyze process workflows and operational data to identify opportunities for efficiency improvements and operational streamlining., • Assist in developing process maps, performance metrics, and dashboards for CMC and Clinical Supply operations., • Support cross-functional coordination with internal teams and external manufacturing partners., • Contribute to technical documentation, process improvement initiatives, and operational reports., • Assist with tracking timelines and deliverables related to clinical supply manufacturing campaigns., • Present findings and recommendations to leadership at the conclusion of the internship., • Respond to requests from leadership to support various projects and initiatives that may arise., • Maintain clear communication with colleagues and Department Head., • Perform administrative tasks as needed, • Currently pursuing a Bachelor's degree in:, • Chemical Engineering (preferred), • Pharmaceutical Sciences, • Chemistry or related engineering/science discipline, • Entering Junior or Senior year in Fall 2026., • Strong analytical and problem-solving skills., • Ability to organize and analyze operational or technical data., • Proficiency in Excel, PowerPoint, and basic data analysis tools., • Excellent communication (written and verbal) and teamwork skills., • Prior work experience in Pharmaceutical industry is not required, but must be proficient in general computer skills, including, but not limited to Microsoft Office., • Highly organized with strong focus on accuracy, • Quick learner with determination to accomplish assignments within the established timeline, • Flexibility to adapt to changing priorities based on business needs, • Fluency in English Language

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles. We are looking for our next Operations Manager within our Operations Team. The Operations Manager will be responsible for providing leadership and direction for the site's technical operations team and driving plant continuous improvement initiatives. The role directs and coordinates all activities of the process and automation engineers and partners with the Manufacturing Technology team and Capital Engineering team to ensure proper prioritization and technical oversight of operations and ensure continuous improvement activities are on track. The Operations Manager is a key member of the Newark site leadership team and supports and establishes a strong safety and productive culture. This position is located in Newark, Delaware. Compensation: The current salary range for this role is estimated to be $146,367 - $176,052. In addition, this position may also be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location. What You'll Do: • Serves as proactive member of Management Team by providing technical expertise, continuous improvement leadership, and identifying and acting upon cost saving opportunities;, • Actively participates on the Site Leadership team to set direction and optimize overall site productivity;, • Shows courageous leadership by coaching, asking questions, and intervening when needed., • Challenges status quo and past norms to make the operation more safe and effective:, • Utilize process knowledge to drive performance with technical support teams;, • Interacts with other members of the leadership team, plant staff, and divisional cross-functional groups to optimize plant operations;, • Drive enforcement and continuous improvement of the Roquette Operating System for the site;, • Lead GEMBA program for leaders and managers;, • Ensure effective determination and implementation of operations corrective and preventive actions (CAPA);, • Lead and coordinate sitewide 5S activities;, • Ensure timely and effective execution of operations RCA investigations;, • Lead site efforts for productivity improvement plans and VCP (value creation plan);, • Lead technical team to continuously improve plant OEE;, • Ensure operations department objectives are aligned with site and business direction;, • Improve operations efficiencies and develop and implement best practices;, • Ensure effective daily management of the Operations technical team, which includes technical staff, and resident contractors when applicable;, • Provide technical expertise to analyze and resolve recurring issues that impact plant uptime;, • Implement Lean concepts, improve equipment reliability, operations productivity and optimize overall asset life cycle costs;, • Lead team to provide technical support in order to plan department operations;, • Lead team to provide data needed for bill of materials, yield, OEE, and other key metrics;, • Create, review, manage and share sitewide KPI's;, • Reviews production and operating reports and resolves operational, manufacturing, and maintenance problems to ensure minimum costs and prevent operational delay;, • Continuously works to improve the total cost of production (raw material, conversion cost and activity rate, etc.). May take a leadership role in maintaining the budget as delegated by the Site Leader;, • Develops strong partnerships with support functions such as EHS, Maintenance, Supply Chain, and others to drive improvement in the organization and assure alignment;, • Provide operational resources to support investments in projects that improves quality and capability to meet internal and external customer needs and corporate, group, division and site goals;, • Ensures the operation team is fully prepared for immediate response situations, including where technical resources might be needed to analyze process conditions and guide the response;, • Encourage identification and prevention of non-conformance to quality procedures and specifications;, • Ensure that investigations are conducted into any process deviations or non-conformances and develop and implement programs to prevent re-occurrence;, • Understand and anticipate customer needs and implement performance measurements responsive to such needs;, • Communicate continuous improvements in key measurements including on time delivery, product quality and process capability; What You'll Need: Education: • B.S. Degree in Chemical Engineering (highly preferred), Chemistry or related technical discipline or equivalent combination of education and experience., • Experience in food/pharma manufacturing operations preferred., • 5+ years' experience in an industrial setting in a learning, EH&S, Manufacturing, HR, Quality or work process related role preferred;, • Strong analytical, personal computer, organizational and leadership abilities., • Strong communication skills (written, verbal, and listening) and interpersonal skills., • Strong problem-solving ability., • Expert knowledge of process technology and Avicel manufacturing preferred., • Strong project management and communication skills;, • Ability to manage time, balance priorities, and manage conflict;, • Good analytical skills with demonstrated ability to consistently solve problems in a decisive and efficient manner;, • Computer skills (word processing, spreadsheets, graphics & database);, • Good working knowledge and understanding of Enterprise Resource Planning (ERP) systems with working knowledge of SAP highly desirable;, • Lean Six Sigma experience a plus;, • Experience in heavy industrial or chemical technical applications;, • Experience managing in a Union environment a plus;, • MBA helpful but not required. Work Environment • This is a full-time on-site position. Days and flexible hours of work are required to meet facility demands. AAP/EEO Statement Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. "AAP, EEO, Drug-Free Workplace" Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. If you identify yourself in this position, please apply byuploading your resume and let's start the journey together! Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences. Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws. As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach. To find out more about our products, values and sustainable development ambitions visit us at ___ and at ___

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Must have two (2) years’ experience in pharmaceutical production. Experience in Production Planning & Scheduling, Supply Chain Coordination, Lean Manufacturing / Six Sigma, CAPA Management (Corrective and Preventive Actions) and Resource Allocation (Man, Machine, Material) are required. Production

Job Description Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a energy and utility company in Newark, NJ. This is a Hybrid role see details below. This role will be onsite and available to candidates local to the Newark, NJ area. We are interested in every qualified candidate who is eligible to work in the United States. Unfortunately, we are not able to sponsor visas or employ corp-to-corp Business Development Manager - Energy Efficiency Program Support Manager Location: Hybrid – Newark, NJ - 1 day per week Supporting Clients in Central and South New Jersey 12 Month Contract Pay Rate: $60-$65/hr w2 Mileage Reimbursement Job Summary Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services Ensure vendor and employee compliance with safety protocols and practices Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services Enhance program delivery/customer experience and resolve business/customer issues Develop and maintain the processes for implementing energy efficiency projects and programs in accordance with requirements for BPU approved programs Provide oversight for business controls, process improvement and compliance Ensure accurate invoice processing Identify and implement process improvements and automate where possible Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations Prepare and present program and project status reports to senior management Assist with special projects as necessary This leader must foster an inclusive work environment and respect all aspects of diversity. Must demonstrate and value differences in others' strengths, perspectives, approaches, and personal choices During storm restoration efforts, may be required to perform functions outside of routine duties and on a schedule that may be different from normal operation Job Responsibilities Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services; manage employee performance; ensure safety protocols and practices are followed. Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services, enhance program delivery/customer experience and resolve business issues. Develop and maintain program processes. Provide oversight for business controls, process improvement and compliance. Ensure accurate invoice processing. Identify and implement process improvements and automate where possible. Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations and regulatory requirements; Prepare and present program and project status reports to senior management. Required: B.S. Degree in Management, Engineering, Business, Finance or other relevant field or equivalent work experience plus 7 years of experience in the space of energy efficiency programs, construction, or related fields. In lieu of a degree, 11 years of experience in the space of energy efficiency programs, construction, or related field. Experience managing vendor performance, and leading cross-functional teams; Energy Efficiency or Electric Vehicle program experience Management/leadership experience working with cross-functional teams Valid US driver's license Desired: Certified Energy Manager (CEM) certification MBA or Advanced Degree Company DescriptionA WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.

Job Description Job Summary The Compounder is responsible for accurately blending, mixing, and compounding flavor and fragrance formulas according to established batch records and quality standards. This role ensures products are manufactured safely, consistently, and in compliance with Good Manufacturing Practices (GMP) and company procedures. Key Responsibilities • Compound flavors and fragrances by accurately weighing, measuring, and blending raw materials per batch formulas, • Follow batch records, SOPs, and production schedules to ensure on-time manufacturing, • Verify raw materials, lot numbers, and quantities prior to use, • Operate mixing, blending, and compounding equipment safely and efficiently, • Perform in-process quality checks and report any deviations or inconsistencies, • Maintain accurate production documentation, including batch records and inventory usage, • Clean, sanitize, and maintain compounding equipment and work areas in compliance with GMP standards, • Adhere to all safety policies, including PPE requirements and proper chemical handling, • High school diploma or equivalent required; technical or manufacturing training preferred, • Previous compounding, blending, or manufacturing experience preferred (flavor, fragrance, food, cosmetic, or pharmaceutical industries a plus), • Strong attention to detail and ability to follow precise formulas and instructions, • Basic math skills for weighing, measuring, and conversions, • Ability to lift up to 50 lbs and stand for extended periods, • Manufacturing and laboratory-adjacent production setting, • Exposure to aromatic compounds and raw materials, • Requires adherence to safety, quality, and sanitation protocolsCompany DescriptionGlobal roofing brand providing homeowners with unrivaled quality and lifetime protection.Global roofing brand providing homeowners with unrivaled quality and lifetime protection.

Job Description POSITION TITLE: Compliance Coordinator POSITION REPORTS TO: Facility Manager Position Summary August Tenth Capital Investments — operating under our new adult-use cannabis brand My Dad’s Stash — is preparing to launch a state-licensed cultivation and processing facility in the coming months. We are building a high-performing team excited to join a ground-floor startup environment and help shape one of New Jersey’s newest and most compliant cannabis operations. We are seeking a Compliance Coordinator who will serve as the primary leader responsible for ensuring operational compliance across cultivation and post-harvest functions. This role oversees regulatory requirements issued by the New Jersey Cannabis Regulatory Commission (CRC), manages SOP development and revisions, supports METRC accuracy, and acts as the facility’s primary point of contact during regulatory inspections. The Compliance Manager will work closely with cultivation, harvest, packaging, and operations teams to ensure all activities are performed in alignment with company policies, safety standards, and state regulations. This position requires a detail-driven, organized, and proactive leader capable of maintaining transparency, accountability, and operational excellence within a fast-growing startup environment. Key Responsibilities • Lead and oversee all compliance efforts across cultivation and post-harvest operations to ensure adherence to New Jersey CRC regulations and all applicable state requirements., • Serve as the facility’s primary point of contact for regulatory inspections, audits, site visits, and corrective action implementation., • Develop, review, and maintain Standard Operating Procedures (SOPs) for cultivation, sanitation, inventory tracking, waste disposal, and operational compliance while managing document control and version updates., • Conduct internal compliance audits of METRC data, plant and package inventories, plant movement records, waste logs, harvest batch records, and facility documentation., • Identify discrepancies within METRC or seed-to-sale tracking systems and collaborate with department leaders to resolve issues promptly and maintain accurate records., • Monitor regulatory updates and policy changes issued by the New Jersey Cannabis Regulatory Commission and communicate relevant updates to leadership and staff., • Develop and deliver compliance training programs for new hires and ongoing employee education to ensure consistent understanding of regulatory requirements and company procedures., • Work collaboratively with cultivation, harvest, post-harvest, and packaging teams to ensure compliance is integrated into daily operations including plant tracking, labeling, waste disposal, and documentation procedures., • Review product labeling and packaging information to ensure all required warnings, batch information, testing verification, and CRC-required disclosures are accurate and compliant., • Prepare and maintain regulatory reports, inspection records, training logs, audit documentation, and other compliance-related records., • Track key compliance indicators and operational risk factors while working with department leaders to implement corrective and preventive action plans when needed., • Ensure compliance issues are documented, investigated, and resolved appropriately and in a timely manner., • Maintain professional working relationships with regulators, inspectors, and third-party partners while ensuring the facility remains inspection-ready., • Participate in cross-department meetings to ensure new processes, facility changes, and equipment installations meet regulatory requirements., • The ideal candidate will have three or more years of compliance experience, preferably within the cannabis industry or other regulated industries such as pharmaceutical manufacturing, agriculture, food production, or regulated manufacturing environments., • Candidates should have a strong understanding of New Jersey cannabis laws and regulations (N.J.A.C. 17:30) and experience working within regulatory compliance frameworks., • Experience with METRC or other seed-to-sale tracking systems and conducting inventory reconciliations or internal compliance audits is strongly preferred., • The candidate must demonstrate exceptional organizational skills, strong attention to detail, and the ability to interpret regulations and translate them into practical operational procedures., • Strong written and verbal communication skills are required, along with the ability to train and support employees on compliance practices and SOP implementation., • Candidates should be comfortable managing multiple projects and deadlines within a fast-paced startup environment and be proficient in Microsoft Office applications including Word, Excel, and PowerPoint., • Applicants must be 21 years of age or older and able to meet all New Jersey Cannabis Regulatory Commission requirements, including background checks, fingerprinting, and agent registration., • A Bachelor’s degree is preferred, though equivalent experience in regulatory compliance or cannabis operations may be considered.Company DescriptionWe are a licensed cannabis cultivation facility in North Plainfield, NJ focused on producing high-quality cannabis through modern cultivation techniques. As a growing company in New Jersey’s emerging cannabis industry, we are building a team of hardworking individuals who value attention to detail, teamwork, and professionalism. Our goal is to create a positive workplace where employees can grow alongside the company.We are a licensed cannabis cultivation facility in North Plainfield, NJ focused on producing high-quality cannabis through modern cultivation techniques. As a growing company in New Jersey’s emerging cannabis industry, we are building a team of hardworking individuals who value attention to detail, teamwork, and professionalism. Our goal is to create a positive workplace where employees can grow alongside the company.

Job Description Job Summary The Packer is responsible for accurately packaging fragrance and flavor products in a clean, safe, and regulated manufacturing environment. This role supports production by ensuring finished goods are packed, labeled, and prepared for shipment in compliance with company quality standards and Good Manufacturing Practices (GMP). Key Responsibilities • Package fragrance and flavor products according to batch records, work orders, and quality specifications, • Label containers accurately with lot numbers, product codes, and expiration dates, • Inspect finished products for defects, leaks, or inconsistencies prior to packing, • Maintain a clean and organized workstation in compliance with GMP, safety, and sanitation standards, • Follow all SOPs related to handling aromatic, liquid, and powdered materials, • Assist with weighing, sealing, boxing, and palletizing finished goods, • Document production counts, packaging data, and quality checks as required, • Support production and quality teams with rework, line changeovers, and inventory staging, • High school diploma or equivalent preferred, • Previous packing or manufacturing experience preferred (fragrance, flavor, food, or pharmaceutical a plus), • Ability to follow detailed instructions and work in a fast-paced environment, • Strong attention to detail and quality accuracy, • Ability to stand for long periods and lift up to 40–50 lbs, • Manufacturing and production facility, • Exposure to fragrances, flavors, and raw materials, • Temperature-controlled environment with standing and repetitive tasksCompany DescriptionGlobal roofing brand providing homeowners with unrivaled quality and lifetime protection.Global roofing brand providing homeowners with unrivaled quality and lifetime protection.

Job Description Job description Granulation Technology, Inc. is a leading pharmaceutical manufacturer specializing in high-quality OTC (over-the-counter) products. As a fast-growing, Indian-owned and majority women-owned company, we are committed to excellence, innovation, and customer satisfaction. Role Overview: We are seeking a results-driven Pharmaceutical OTC Sales Representative to expand our market presence, secure new accounts, and maintain strong relationships with key customers. This is an exciting opportunity for a sales professional with experience in the pharmaceutical OTC industry. Responsibilities: ✅ Identify and develop new sales opportunities within the OTC pharmaceutical market. ✅ Build and maintain relationships with distributors, retailers, and healthcare providers. ✅ Present and promote our OTC products to potential clients. ✅ Negotiate contracts, pricing, and supply agreements. ✅ Stay updated on industry trends, competitor activity, and market demands. ✅ Collaborate with internal teams (marketing, regulatory, and logistics) to ensure customer satisfaction. ✅ Meet or exceed sales targets and KPIs. Qualifications: Experience: 10+ years in OTC pharmaceutical sales. Skills: Strong negotiation, relationship-building, and communication skills. Knowledge: Familiarity with the OTC market, retail distribution, and pharmacy channels. Self-Motivated: Ability to work independently and drive results. Travel: Willingness to travel as needed for client meetings and industry events. Why Join Us? ✨ Opportunity to work with a growing pharmaceutical company. ✨ Competitive salary with uncapped commission potential. ✨ Flexible work environment with career growth opportunities. ✨ Be part of a dynamic, diverse, and innovative team. Company DescriptionGranulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.Granulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.

Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Manage CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description 2nd shift: 3pm-11pm Temp to Perm A 2nd shift Maintenance Technician ensures the continuous operation of highly specialized equipment and cleanroom facilities during evening hours. They are responsible for troubleshooting, repairing, and performing preventative maintenance (PM) on complex machinery, such as autoclaves, bioreactors, and automated packaging systems, while strictly adhering to Good Manufacturing Practices (cGMP) and OSHA safety standards. Key Responsibilities • Preventive & Corrective Maintenance: Perform scheduled PMs, diagnose mechanical/electrical failures, and repair equipment to minimize downtime, often working independently with minimal supervision., • Equipment Specialization: Maintain lab-specific equipment, including CO2 incubators, bioreactors, cryogenics, clean steam generators, and water purification systems (RO/DI)., • GMP & Documentation: Accurately document all maintenance activities, repairs, and inspections in a Computerized Maintenance Management System (CMMS) according to Good Documentation Practices (GDP)., • Safety & Compliance: Maintain a clean, 5S-compliant work area, wear appropriate Personal Protective Equipment (PPE) such as PAPR, and comply with safety regulations (OSHA, EPA, FDA)., • Technical Expertise: Strong knowledge of electro-mechanical, pneumatic, and hydraulic systems, with experience in troubleshooting PLC-controlled equipment., • Education/Experience: High School diploma or GED required, with a technical school certificate or equivalent experience (often 3-5+ years) in a manufacturing or pharmaceutical environment., • Regulatory Knowledge: Familiarity with cGMP, FDA, and OSHA requirements., • Physical Ability: Ability to lift up to 50 lbs, work in confined spaces, and stand for extended periods., • Autonomy: Higher need for independent problem-solving due to reduced management presence., • Support: Often responsible for covering both production machinery and facility-wide utilities. Company DescriptionFortune 100 Homebuilding companyFortune 100 Homebuilding company

Job Description Instrumentation Controls Technician Location: Lyndhurst, NJ Schedule: Monday – Friday | 2:00 PM – 10:30 PM (2nd Shift) Pay: $35 – $40 per hour Type: Contract-to-Hire Are you the kind of person who can look at a control panel, hear a weird machine noise, and immediately start diagnosing the problem in your head? If PLCs, instrumentation, and troubleshooting industrial equipment are your thing, this could be a great fit. We are seeking an Instrumentation Controls Technician to support a busy manufacturing facility in Lyndhurst, NJ. In this role, you will work with plant systems, instrumentation, and control equipment to ensure operations run safely and efficiently. You will also help maintain calibration programs, troubleshoot automation issues, and support plant operations when technical challenges arise. If you enjoy solving technical problems and working hands-on with equipment and control systems, this is a strong opportunity with a company that values technical expertise. What You'll Do * Troubleshoot and maintain PLC and control systems supporting plant equipment * Maintain and repair instrumentation, sensors, and electrical systems * Analyze and test computer control systems based on system design specifications * Support machine operating systems and control programs * Perform instrument calibration and calibration documentation * Manage calibration schedules and maintain compliance with ISO 9000 requirements * Diagnose issues with labeling equipment and automated systems * Perform scheduled maintenance on electrical and electronic devices * Provide rotational weekend on-call support for plant operations when required What We're Looking For * Strong troubleshooting and analytical skills * Solid electrical and controls background * Experience with PLCs (Allen-Bradley preferred) * Experience with pneumatic and hydraulic systems * Ability to read technical drawings, P&IDs, and ladder logic diagrams * Experience performing instrument calibration * Strong communication skills and ability to work independently or on a team * Experience in industrial manufacturing environments such as chemical, pharmaceutical, or food processing is preferred * Technical school training or related degree preferred * Experience with CMMS systems and smart instruments is a plus Additional Details * Schedule: Monday–Friday, 2:00 PM – 10:30 PM * Pay: $35–$40/hour * On-Call: Weekend rotation for plant support * Position Type: Contract-to-Hire * Location: Lyndhurst, NJ About Zing Recruiting Zing Recruiting is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, or any other protected status under federal, state, or local law. We are committed to fostering a diverse and inclusive workplace. #ZINGZIP #ZINGNJ Company DescriptionZing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.Zing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionDescription: AAF International offers the most comprehensive clean air solutions available across the globe. Selling under the American Air Filter® and the AAF International® brand names, AAF International has been an industry pioneer since 1921 with manufacturing operations in 22 countries and over 6000 employees globally. Our products are the industry benchmarks for quality and performance. Our applications include commercial, industrial and residential solutions from the filters used in your home to the most critical cleanroom and power generation applications. We are a member of the Daikin Group, the world's largest air conditioning provider with $30 billion in revenue and over 98,000 employees worldwide. Founded in 1924, Daikin has grown into a diversified industrial manufacturing company offering solutions in clean, air, air conditioning, refrigeration, chemicals, oil hydraulics, defense systems and electronics. Our culture of continuous improvement, safety and world class operations is driven by our people-centered management philosophy. This philosophy is built around mutual selection: that while AAF seeks top talent people to join and deliver on our team, we also want each team member to receive job satisfaction, growth & development, and continued happiness in being a long-term member of the AAF family. This is fueled by our belief in treating our people, our supply partners, our customers and our environment with the trust and respect we each require, and our passion to give back to our community for our success. Read more about our philosophy at: AAF International is an Equal Opportunity Employer M/F/Disability/Veteran. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, sexual orientation, gender identity, national origin, citizenship, veteran status, uniform servicemember status, age, disability or any other legally recognized protected personal characteristics. Position Objective: This position will report to the regional branch in New Jersey and work out of their home, ideally located in the territory. The territory for this position covers Nassau and Suffolk counties and the outer boroughs of Queens, Brooklyn, Bronx and Staten Island. Achieves maximum sales profitability, growth and account penetration within an assigned territory and/or market segment by effectively selling the Company’s products. Contacts and secures current and new business accounts/customers. Key Accountabilities: • Promotes/sells/secures orders from existing and prospective customers through a relationship-based sales approach highlighting the advantages/value proposition., • Demonstrates products to existing and potential customers and assists them in selecting those best suited to their needs., • Manages sales goals - profit and budget expenses., • Establishes, develops and maintains business relationships with current customers and prospective customers in the assigned territory/market segment to maintain current and generate new business., • Researches sources for developing prospective customers and for information to determine their potential., • Develops clear and effective written proposals and quotations for current and prospective customers., • Expedites the resolution of customer problems and complaints., • Coordinates sales effort with marketing, sales management, accounting, logistics and technical services., • Analyzes the territory/market’s potential and determines the value of existing and prospective customers to the Company., • Creates and manages a customer value plan for existing customers highlighting sales profile, share and value opportunities., • Provides management with detailed information on customer needs, problems, interests, competitive activities, and potential for new products., • Stays current with product applications, technical services, market conditions, competitive activities, and marketing trends and activities., • Participates in trade shows and conventions as required., • Perform other related duties as assigned as required. Requirements: Position Requirements: • Bachelor’s degree from an accredited university in Business or related field preferred;, • 5+ years' prior selling experience;, • Understanding and experience with high value-added product selling, pricing, and negotiation;, • Experience selling to healthcare and pharmaceutical facilities a plus;, • Ability to communicate a technical concept or value added benefit to achieve buy-in from diverse teams to meet sales targets and profitability;, • A history of consistently delivering on expectations for growth and profitability must be demonstrated;, • A team player that possesses a natural way of influencing, both internally and externally;, • A self-starter with a creative eye to implement marketing and promotional campaigns designed to achieve specific growth objectives regionally and nationally;, • Must be proficient in Microsoft Office (Word, Excel, PowerPoint);, • SAP or CRM experience, Salesforce preferred.

Job DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle. • Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients., • Support routine GMP testing as assigned. Mentor and train team members, • Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements., • Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports., • Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data., • Identify, evaluate, and implement continuous business process improvements., • Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)., • Provide support during laboratory investigations., • Train QC personnel during method transfer and validation. Provide support during equipment qualification., • Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices., • Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures., • Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.REQUIREMENT, • B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products., • 8-10 years of experience in the areas of method development, validation, and transfer., • Direct GMP Experience., • Proficiency in project management skills and tools., • Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc., • Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs., • Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required., • Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution., • Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team., • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction., • Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external., • Must be familiar with GMP lab environment and Aseptic techniques.Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Electrical Factory Inspector (Remote/Travel) responsibilities include, but are not limited to, the following: • Support department objectives and company goals, • Be a team player, • Sustain a positive, enthusiastic and professional attitude at all times, • Accommodate requests with a smile and “let me see what I can do” attitude, • Adhere to manager directives, • Maintain a professional appearance and demeanor, • Arrive on time, properly dressed and prepared to work, • Perform all duties in a timely, accurate, honest and professional manner, • Communicate with customers professionally and in accordance with customer service standards, • Surveillance inspections of factories to assure products remain in compliance with conditions of granted certification., • Other duties assigned by management.Qualifications Basic Minimum Education Qualifications: • Knowledge of electronics, • Certification in Electronics, ideal but not required, • Willing to travel - This position requires 90% - 100% travel, • Able to rent a car, • Willing to work overtime and remote, • Cannot be on any no fly list, • Clean driver record, • Ability to maintain confidentially, • Needs to be receptive to and accepting guidance from others, • Ability to deal with difficult people and problems, • Able to work well in a team environment, • Able to work in a diverse group of people, • Attention to detail, • Ability to multi-task and prioritize assignments, • Able to sit or stand for long periods of time, • Able to lift up to 30 pounds Additional Information Position is full-time travel & hybrid, working Monday - Friday 8:00 am to 5:00 pm, with overtime as needed. • Compensation: $50,000 - $70,000, • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job Description We’re seeking a Warehouse Group Leader to oversee inventory handling, personnel coordination, and day-to-day warehouse operations within a food-grade manufacturing environment. This role requires strong leadership, attention to detail, and the ability to manage product flow, documentation accuracy, and compliance with all food safety, GMP, and company standards. You’ll lead a shift of warehouse personnel, ensure accurate receiving and inventory control, coordinate outbound shipments, and support safe, efficient warehouse operations. Compensation • $22 hr, • Shift Leadership & Team Coordination – Assign tasks, supervise warehouse personnel, provide training, and ensure smooth shift operations. Step into full departmental responsibility when the Warehouse Manager is absent., • Receiving & Inventory Management – Receive finished goods, verify materials against invoices, maintain accurate inventory counts for raw, packaging, and finished goods, and ensure all items are properly tagged, labeled, and stored., • Shipping & Material Handling – Oversee loading and unloading of freight, ensure FIFO is followed for incoming and outgoing products, coordinate transportation schedules, and validate outbound accuracy., • Compliance, Documentation & SAP Use – Maintain complete and accurate paperwork for all inbound/outbound transactions; operate SAP warehouse applications and handheld scanners for receiving, posting, and tracking materials., • Quality, GMP & Food Safety Standards – Ensure all warehouse activities follow GMP, food-safety, and safety guidelines. Maintain a clean work area, ensure tools/equipment function properly, and immediately report discrepancies or damages., • Forklift Operation & Safety – Complete forklift and trailer inspections, maintain a zero-damage standard, and uphold a clean safety record in accordance with company policies., • Supplier & Customer Coordination – Communicate with suppliers regarding delivery schedules, prepare product samples as needed, and assist in reviewing open sales orders to ensure adequate inventory allocation Qualifications • Experience – Minimum 2 years of warehouse experience in a manufacturing environment, ideally within food, pharmaceutical, or nutraceutical industries., • Leadership & Teamwork – Demonstrated ability to lead a shift, train staff, delegate tasks, and maintain smooth warehouse operations., • Technical Skills – Experience with handheld scanners; ability to use SAP or similar warehouse management systems; strong understanding of inventory practices and FIFO., • Forklift Certification – Valid forklift license/certification with a strong safety record., • Documentation & Compliance – Ability to complete and manage paperwork accurately while following SOPs, GMPs, and food-safety guidelines., • Communication – Ability to read, write, and speak English effectively; strong coordination and reporting skills., • $22 hr, • Medical, dental, vision

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionJob Summary: Instrument and Controls Engineer:The Instrument and Controls Technician is involved with the successful daily operation of the oil refining facility, and the modification and alteration of the plants automated control and power systems to accommodate business needs and ensure high plant availability. This requires close collaboration with other employees and management staff to ensure safe work and to set or re-set job priorities. Documentation, as required to document changes in plant physical or logic changes, and documentation to meet our goals of safety first, quality work and compliance with our customers’ requirements and concerns. Qualifications: Instrument and Controls Engineer: • High School Diploma or GED with at least 10 years I&E (I&C) experience in a chemical, food, pharmaceutical manufacturing environment. Familiarity with PLC based controls systems such as GE or Allen Bradley in a manufacturing environment., • Ability to analyze and interpret technical problems related to instrumentation or PLC logic., • Ability to read and understand company policies and procedures, technical datasheets or literature, P&IDs, electrical drawings (One-line drawings, loop drawings, control circuits, etc), • Ability to effectively present information either verbally or via written document (e-mail, MS Word/Excel, CMMS, etc) and respond to questions from groups of managers, co-workers, customers, and the general work force., • Ability to work with and apply mathematical concepts to practical situations., • Preferred: New Jersey Licensed Electrician (or working towards license), • Preferred: ISA Certification (Certified Control System Technician, Certified Industrial Electrician, Certified Instrument Technician)Duties & Responsibilities: Instrument and Controls Engineer:, • Monitor, repair, maintain and troubleshoot all field instrumentation, electrical equipment and controls systems including plant safety systems and plant power systems., • Install, loop check, maintain and troubleshooting process control systems comprised of transmitters, controllers, and valves operating in a PLC system., • Calibrate, monitor, repair, maintain, label and document all field instruments such as transmitters, controllers, valves, PLCs, plant safety systems, plant power systems, utility systems (HVAC), pH and conductivity meters, • Install, maintain, and troubleshoot electrical distribution and protection circuits up to 480VAC., • Fabricate and install rigid and flexible conduit, and run power and control wiring based on electrical code requirements, • Properly select, install and wire 120V-480V motors, single phase to three phase based on needs, • Strong working knowledge of National Electrical Code (NFPA 70), • Evaluate current instrumentation technology for process equipment and make recommendations for improvements., • Ensure all work orders are completed, documented and closed out in the site CMMS system, as per procedure., • Provide on-call support during assigned weeks to ensure 24/7 coverage, • Provide practical solutions to operations/ controls problems., • Scope, estimate and execute small capital / maintenance projects along with maintenance manager/ project director/ operations, etc., • Train other employees considering their needs and company needs., • Oversee the work by contractors as required on site to ensure safe and quality performance.

Job DescriptionCompany Description With more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of systems and products for commercial and residential construction, as well as the transportation, marine, automotive, and renewable energy manufacturing industries. Sika is a specialty chemical company with a globally leading position in the development and production of systems and products for bonding, sealing, damping, reinforcing, and protection in the building sector and industry. Sika has subsidiaries in 103 countries around the world, produces in over 400 factories, and develops innovative technologies for customers worldwide. In doing so, it plays a crucial role in enabling the transformation of the construction and transportation industries toward greater environmental compatibility. Approximately 33,000 employees generated CHF11.20 billion in sales in 2025. Job Description Broad Function and Purpose of Position: Individual will work a 2nd shift work schedule and Document, analyze and test computer control systems related to user system design specifications and machine operating systems. Perform maintenance and calibration activities on devices and instruments. Troubleshoot existing equipment and control systems for efficiency and operation. Specific Responsibilities: • Application of systems analysis techniques and procedures, including consulting with users to determine hardware, software, or system functional specifications for control systems., • Documentation, analysis and testing of computer systems or programs, based on and related to user system design specifications., • Documentation, testing of computer programs related to machine operating systems., • Maintain, repair, and troubleshoot devices/instruments and labeling equipment., • Manage the Calibration Program, including schedule of calibrations, perform calibrations on specific instruments, maintain Calibration Manager Software compliant with ISO 9000 requirements, etc., • Perform scheduled maintenance of specific electrical and electronic devices and systems., • Provide weekend support, including on-site troubleshooting, if needed, to the plant operations in the field of controls.Qualifications, • Excellent analyzing, testing, and troubleshooting skills and organized approach to problem-solving., • Strong electrical background., • Experience with computer systems, programs, and PLC’s (Allen-Bradley desirable). Also, with pneumatic and hydraulic devices., • Ability to read technical drawings (P & ID’s), ladder logic diagrams; perform instrument calibrations. Good communication skills, ability to work independently or on a team., • Experience in ISO 9000 and/or process type (chemical/pharmaceutical/food) industrial facilities, • 3-5 years’ experience or minim 1 year plus Technical School. College degree a plus. Additional Information · 401k with Generous Company Match · Bonuses · Medical, Dental, and Vision Benefits · Paid Parental Leave · Life Insurance · Disability Insurance · Paid time off, paid holidays · Floating holidays + Paid Volunteer Time · Wellness/Fitness Reimbursements · Education Assistance · Professional Development Opportunities · Employee Referral Program & More! Sika fosters a culture of entrepreneurship, empowering each individual to make decisions, learn from experiences, and shape their own career path. The safety and well-being of employees are top priorities at Sika, with a strong commitment to open communication and maintaining a safe workplace. In addition, Sika actively contributes to the community and promotes sustainability by giving back, minimizing environmental impact, and embracing social responsibility. Sika Corporation is committed to a work environment that supports, inspires, and respects all individuals that apply. As an equal opportunity employer Sika will consider all qualified applicants without discrimination on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, national or ethnic origin, or other protected characteristics. We offer competitive salaries, aligned with local market benchmarks and the specific scope and responsibilities of each role. Compensation is determined based skills relevant to the position, education and/or training. We are committed to fair and equitable pay practices in accordance with applicable laws and regulations.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAbout the Company LTS Lohmann Therapy Systems is a global leader in transdermal and oral thin‑film drug delivery technologies. Our teams have pioneered breakthroughs such as the first contraceptive patch, nicotine patch, oral active ingredient film, and Parkinson’s patch. When you join LTS, you become part of a team that continues to shape the future of patient care and bring life‑changing therapies to market. At LTS, our purpose drives everything we do: We CARE. We CREATE. We DELIVER. We’re committed to fostering an employee experience that reflects our innovation — supportive, collaborative, and empowering. Across our New Jersey and Minnesota locations, you’ll work alongside knowledgeable experts on diverse projects in an environment where every day is different and your contributions truly matter. Job Summary As a Manufacturing and Process Engineer, you will lead equipment reliability efforts for the Fabrication department at the West Caldwell, NJ facility. This includes improving preventive maintenance strategies, implementing Total Productive Maintenance (TPM) systems, and driving Overall Equipment Effectiveness (OEE) measurement. You will partner closely with production leadership to integrate TPM, OEE, and reliability methodologies into daily management—advancing operational excellence and continuous improvement. This is a full time, onsite role located in West Caldwell, NJ • Schedule: Monday–Friday, 8:00 AM–4:30 PM Key Responsibilities • Lead equipment reliability improvement initiatives and long‑term strategic projects., • Enhance and optimize preventive maintenance programs and procedures., • Implement TPM methodologies across the Fabrication department., • Establish and monitor OEE metrics and performance KPIs., • Troubleshoot and support equipment repair activities as needed., • Create, revise, and maintain equipment‑related procedures and documentation., • Partner with cross‑functional teams on change control and continuous improvement efforts., • Lead Lean initiatives and reliability‑focused problem‑solving activities., • Conduct investigations of equipment failures and develop corrective and preventive actions., • Actively participate in departmental and cross‑functional meetings. Minimum Qualifications • Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or related field., • 2–3 years of experience in pharmaceutical, medical device, or industrial manufacturing., • Strong communication skills and solid mathematical/analytical ability., • Ability to wear required PPE: safety glasses, hearing protection, respirator, latex gloves, and Tyvek suit. Preferred Qualifications • Experience with TPM, OEE, and equipment reliability programs., • Prior hands‑on exposure in a regulated manufacturing environment. If this sounds like you, we want to hear from you! LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc., • Execute IQ/OQ and /or PQ protocols, • Prepare final reports for executed protocols, • Prepare final reports for vendor IQ, OQ and/or PQ protocols, • Review of executed IQ/OQ/PQ protocols and raw data, • Perform periodic review/requalification of validated equipment, systems and cleanrooms, • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met, • Assembling validation related documents; and filing/archiving approved documents, • Maintaining electronic records.REQUIREMENTS, • BS/BA in engineering or a related Science discipline, • 3-7 + years of validation experience, • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc., • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11., • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary., • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management., • Must be a dedicated self-starter with a high energy level and able to achieve results., • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution., • Good time management skills to manage and meet deadlines., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment., • Good computer skills and Microsoft Office knowledge., • Ability to multi-task team is essential., • Flexible and able to adapt to company growth and evolving responsibilities., • Highly organized, detail oriented, and ability to manage multiple priorities., • Ability to perform the job under direct or indirect supervision, • Must have the ability to work in a team-oriented environment and with clients, • Must have the ability to work with specialized equipmentMay occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical Associate II, responsibilities include: • Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations, • Performs maintenance, monitoring, and troubleshooting of pertinent equipment, • Performs and assists in the training of other Quality Control technicians, • Maintains training records and coordinates records retention with Document Control and Training groups, • Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines, • Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable, • Participates in managing QC materials and supplies, • Performs and assists in equipment and method qualification/validation activities as needed, • Performs reagent and media preparation, • Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment, • Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results, • Initiates, investigates, and prepares deviation reports with input from assigned supervisor, • Brainstorms and implements corrective and preventive actions, as and when applicable, • Documents training and execution of shipping test samples to contract laboratories for testing, • Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Communicates effectively with other co-workers, departments, management and clients, • Eventually serves as a lead and/or co-lead for client projects, • Additional tasks as assignedREQUIREMENTS, • BA/BS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred, • Prior industrial experience in cell count methodologies preferred, • Prior academic and/or industrial cell therapeutic experience preferred, • Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry, • Proficient with computer software such as: Microsoft Office, Visio, • Strong written and oral communication skills, • Strong presentational skills preferred, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.Other Information, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Analytical Associate II must be able to work in a laboratory environment for an extended period., • Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hearPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. QC Analytical Associate I is available as well.

Job DescriptionProvides administrative and secretarial support for the vice president and department. RESPONSIBILITIES • Monitors and oversees facility operations for a large biotech site., • Troubleshoots and performs repairs on system issues involving electronic, electrical, pneumatic, hydraulic, and mechanical devices, Johnson Controls Metasys BMS, utility, and water systems., • Supervisor in charge of facility housekeeping staff for second shift., • Generates work orders in SAP, participates in site emergency response and Hazmat activities. Novartis Pharmaceuticals 01 Sep 2005 - 01 May 2014 ENGINEERING TECHNICIAN 1216 5th Avenue New York NY , 10029 OK to contact this employer? - No RESPONSIBILITIES • Repaired, maintained, and calibrated pharmaceutical manufacturing, production and packaging equipment.

Job DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts, • Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs, • Manages all training and compliance activities in the Operations organization, • Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out, • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates, • Supporting and driving special long-term projects and identified and assigned by the PPU Head, • Responsible for creating maintaining and communicating all Operations based KPI’s, • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices, • Approving job specific curriculum for the training and professional development of department staff, • Responsible for streamlining the batch record review process, • Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations, • Driving continuous improvement, • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, • Set team expectations and goals and assists in delivering the business direction for the PPU, • Aligning departmental goals, processes and resource allocation with the organizational strategy, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. REQUIREMENTS, • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience., • 5-10 years of leadership experience or equivalent combination of experience., • Deep Understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system), • Competencies/Candidate Profile, • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Flexible and able to adapt to company growth and evolving responsibilities, • Accountability, integrity, and strong dedication to regulatory compliance, • Strong business and personnel management acumen, • Strong emotional intelligence, • Ability to think strategically and tactically (detail-oriented), • Strong analytical and problem-solving skills, • Strong written and verbal communication skills, • Drive to create and maintain order in a fluid, technically complex environment, • Continuous improvement mindset, • Ability to multi-task is essential, • Must have the ability to work in a team-oriented environment and with clients, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionManufacturing Associate II Allendale, NJ Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills and be flexible in their working hours. • Performs any and all required processing and manipulation required to produce and assess safe and efficacious products, • Proficiently functions within an ISO Class 7 and 6 clean room environments, ensuring personal and product safety, • Consistently produce a high level of documentation accuracy and clarity, • Performs cryopreservation of products using DMSO base solutions and controlled-rate freezers, • Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices, • Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints, • Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation., • Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures, • Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures, • Notifying Management of any deviation that may occur during processing or during equipment maintenance., • Applies knowledge of processing principles and techniques to make good judgement and appropriate decisions, • Performs investigations for deviations and complete deviations and CAPA’s (Corrective and Preventive Actions) in a timely manner, • Supports technology transfers into GMP manufacturing operations, • Participate in the on-call programREQUIREMENTS, • BA/BS or Associate's Degree in a biologics or related field preferred, • 2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing, • Current Medical Technologist license or equivalent is a plus, • Aseptic/cell processing and clean room experience preferred, • Demonstrates tact and courtesy in dealing with others, • Strong work ethic, methodical approach to new challenges, • GLP and GMP experience a plus, • Must be able to work independently and with minimal supervision, • Able to work in fast paced environment at times under pressure and with tight deadlines, • Excellent organizational skills and attention to detail, • Good verbal and written communication skills, • Strong team-oriented interpersonal skills are essential, • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work a flexible schedule that may include nights, weekends and/or holidays, • Training Required; GMP, Gowning training/qualification, Aseptic process qualification (personal media fill), • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyWorking EnvironmentMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work in the cleanroom environment for extended period of timeMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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