• Site Automation, Engineer II

    BeOne Medicines (Pennington, NJ)
    …+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Strong experience with one ... and control panel hardware as required by the job. + Experience with computer systems validation practices (GAMP) + MS Project. **Other Qualifications:** +… more
    BeOne Medicines (09/12/25)
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  • Senior Engineer, Mfg Engr

    J&J Family of Companies (Anasco, PR)
    …, Automation and familiar with Vision Systems , preferred. + Experience in Computer Systems Validation , preferred. + Proven experience with validation ... monitoring and support to manufacturing lines + Provide training on process and validation requirements to operators and engineers + Writes, develops, and implement … more
    J&J Family of Companies (10/01/25)
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  • CSV Specialist

    Mentor Technical Group (NC)
    …environment is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in ... + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts… more
    Mentor Technical Group (09/17/25)
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  • Quality Assurance Process Team Device…

    Lilly (Concord, NC)
    …experience with C&Q / Verification and Validation oversight including automation and computer systems validation + Use process knowledge and control ... understanding of the process and its associated equipment, facilities, computer systems and operations + Lead and...+ Previous use of KNEAT - or other electronic validation software + Previous technical writing experience Lilly is… more
    Lilly (10/01/25)
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  • Application Support Lead

    Lilly (Lebanon, IN)
    …team in executing with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. ... systems (Windows, etc.), and Cisco Infrastructure. Basic understanding of CSV ( Computer system Validation ) & SDLC deliverables. + Experience with disaster… more
    Lilly (09/16/25)
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  • Validation Specialist

    PACIV (Indianapolis, IN)
    …of all departmental computer systems . + Create, revise, and manage Computer Validation System (CSV) documentation to support validation execution and ... is responsible for executing and managing periodic reviews of computer systems , and driving resulting action items...for any deficiencies resulting from periodic reviews. + Update Computer System Validation (CSV) documentation which may… more
    PACIV (09/27/25)
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  • Quality Representative - Floor Support Parenteral

    Lilly (Concord, NC)
    …experience with C&Q / Verification and Validation oversight including automation and computer systems validation + Proficiency with computer ... formulation, filling, and visual inspection + Previous experience with Manufacturing Execution Systems . + Previous use of KNEAT - or other electronic validation more
    Lilly (10/01/25)
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  • QC Laboratory Instrumentation Engineer I/II

    PCI Pharma Services (Bedford, NH)
    …Hands-on experience troubleshooting complex analytical or microbiology equipment + Familiarity with computer systems validation and equipment software + ... of PCI. **What You'll Be Doing** As an Instrumentation Systems Engineer, you'll serve as the go-to expert in...the full lifecycle of QC testing instrumentation: induction, qualification, validation , decommissioning, and beyond + Serve as the main… more
    PCI Pharma Services (07/21/25)
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  • CSV Engineer Spring Co-Op

    J&J Family of Companies (Wilson, NC)
    …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... Site Engineering Group located in Wilson, NC site. This role will be part of our computer system validation team for Wilson, NC site. At Johnson & Johnson, we… more
    J&J Family of Companies (09/19/25)
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  • CLS, Quality Assurance Specialist

    Guidehouse (Bethesda, MD)
    …and corrective action plans, inspection and assessment protocols, records management plans, and computer systems validation . Some of these policies address ... in the development, implementation and coordination of goals, activities and systems in the department's Quality Assurance Program to ensure compliance with… more
    Guidehouse (07/21/25)
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