• 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • Systems Administrator

    Lilly (Branchburg, NJ)
    …upgrading software applications for system management, compliance, and data integrity Partners with Computer System Validation (CSV), IT, QC, and QA to ensure ... implementation, and maintenance of computerized systems. Authors and reviews computer system administration procedures and policies. Serves as technical lead… more
    Lilly (09/10/25)
    - Related Jobs