• FSP - Validation Analyst

    ThermoFisher Scientific (New Brunswick, NJ)
    …GAMP 5, and other applicable global health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting ... system lifecycle activities and 30% management of master systems data. **Key responsibilities:** + Manage and deliver on...Good Testing Practices and solid grasp of cGMPs and Computer System Validations. + Experience with electronic… more
    ThermoFisher Scientific (09/28/25)
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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 ... local and corporate policies). + Provide IDS technical and/or validation direction related to computer system...pharmaceutical regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg… more
    Lilly (09/10/25)
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  • Systems Administrator

    Lilly (Branchburg, NJ)
    …software applications for system management, compliance, and data integrity Partners with Computer System Validation (CSV), IT, QC, and QA to ensure ... Assists in the selection, implementation, and maintenance of computerized systems . Authors and reviews computer system...management, testing, and Qualification, Validation of proposed systems + Provide lab management and system … more
    Lilly (09/10/25)
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  • Associate - System Engineer

    Lilly (Branchburg, NJ)
    …Camstar, or Werum PAS-X). + Minimum 3+ years experience leading or supporting the Computer System Validation of IT platforms including Data Integrity ... and manage multiple tasks simultaneously. * Experience with Computer System Validations. * Experience with Manufacturing Execution Systems and how… more
    Lilly (09/27/25)
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  • Sr. Control Systems Engineer - Multiple…

    Roche (Branchburg, NJ)
    …systems . Assists manufacturing operations in problem solving with regards to the automation systems as well as in the validation of process and facility ... an FDA -regulated manufacturing facility. + Responsible for overall control system concept and support. Ability to program, configure, and troubleshoot PLCs, HMI,… more
    Roche (09/26/25)
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  • Principal Sterilization Microbiologist

    System One (Park Ridge, NJ)
    …+ Sterilization & Microbiological Expertise + Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma ... Leadership & Scientific Rigor + Oversee microbiological method development, validation , and data interpretation for regulatory submissions + Manage complex… more
    System One (09/25/25)
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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. ... late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards.… more
    BeOne Medicines (09/19/25)
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  • Lead Engineer, CSV

    Bristol Myers Squibb (Summit, NJ)
    …no better place than here at BMS with our Cell Therapy team. The **Lead Computer System Validation (CSV) Engineer** supports the successful implementation of ... to the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions,… more
    Bristol Myers Squibb (09/28/25)
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  • Senior Manager CQV

    J&J Family of Companies (Titusville, NJ)
    …and Re-qualification, as well as PQ activities * In partnership with E&PS own Computer Systems Validation , including writing and driving CSV protocols, ... the Project Validation Master Plan (PVMP) and ensure on-time qualified system turnover to the end user. **Key Responsibilities:** * Ownership for the development… more
    J&J Family of Companies (09/17/25)
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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 ... Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up...AND RESPONSIBILITIES * Develop and execute commissioning, qualification, and validation protocols for equipment, facility systems , and… more
    Sokol Materials & Services (07/24/25)
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