• Legend Biotech USA, Inc. (Raritan, NJ)
    …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... quality systems, or learning management systems.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well… more
    HireLifeScience (07/16/25)
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  • Manager, Computer System Validation…

    Bristol Myers Squibb (Summit, NJ)
    …vendors. Experience with technical writing and document development / generation + Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, ... or equivalent experience + Minimum 5 years of experience in FDA -regulated industry **DUTIES AND RESPONSIBILITIES:** **Essential Functions:** Maintains all qualified… more
    Bristol Myers Squibb (10/02/25)
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  • FSP - Validation Analyst

    ThermoFisher Scientific (New Brunswick, NJ)
    …This information may include roadmap/obsolesce data, risk/issue lists, feature requests. + Apply FDA CFR 251 Part 11/EU Annex 11 GAMP 5, and other applicable global ... health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting regulated business processes and computer … more
    ThermoFisher Scientific (09/28/25)
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  • Manager, QC Biochemistry, Hopewell Site

    BeOne Medicines (Pennington, NJ)
    …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Biochemistry laboratory routine operations, including but not limited to validation , SOP revisions, specification updates, testing records, personnel training and,… more
    BeOne Medicines (09/19/25)
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  • Lead Engineer, CSV

    Bristol Myers Squibb (Summit, NJ)
    …place than here at BMS with our Cell Therapy team. The **Lead Computer System Validation (CSV) Engineer** supports the successful implementation of manufacturing ... the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions, this individual… more
    Bristol Myers Squibb (09/28/25)
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  • CQV Engineer Mid-Level

    Sokol Materials & Services (Skillman, NJ)
    …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... risk-based validation approaches. + Strong analytical, problem-solving, and communication skills....Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up… more
    Sokol Materials & Services (07/24/25)
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  • CQV Engineer Senior Level

    Sokol Materials & Services (Skillman, NJ)
    …focused on utilities and facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, ... ICH guidelines. Knowledge, Skills & Abilities: + Proficient in risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. +… more
    Sokol Materials & Services (09/23/25)
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  • Senior Analyst, QC Biochemistry

    BeOne Medicines (Pennington, NJ)
    …related scientific discipline and 2+ years of working experience in an FDA -regulated biotechnology, pharmaceutical company are preferred. ** Computer Skills:** + ... material, intermediates and finished biological products (monoclonal antibodies) under FDA /EU regulations, applicable International Regulations, BeiGene processes and procedures.… more
    BeOne Medicines (08/29/25)
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  • Principal Engineer - Systems

    Lilly (Branchburg, NJ)
    …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. ... local and corporate policies). + Provide IDS technical and/or validation direction related to computer system Change...regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg Privacy, OSHA, etc.)… more
    Lilly (09/10/25)
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  • Senior Manager CQV

    J&J Family of Companies (Titusville, NJ)
    …Re-qualification, as well as PQ activities * In partnership with E&PS own Computer Systems Validation , including writing and driving CSV protocols, Functional ... of contact for all technical matters related to Commissioning, Qualification & Validation . The CAR-T (CQV) Lead is responsible for providing compliance expertise,… more
    J&J Family of Companies (09/17/25)
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