• 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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  • Commissioning & Qualification…

    PACIV (San Juan, PR)
    …+ Performance Qualification + Detailed understanding and experience with current regulations for Computer System Validation , such as FDA cGMPs for the ... related work experience with strong knowledge and hands-on experience of equipment/ system commissioning, qualification (C&Q), and/or validation (CSV) in… more
    PACIV (09/18/25)
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  • Automation Controls Engineer III

    Curia (Albuquerque, NM)
    …fostering skill development and knowledge sharing. + Support Validation and Computer Systems Validation activities to ensure compliance with industry ... maintenance, optimization, and strategic enhancement of control and data acquisition systems for manufacturing, packaging, and support equipment at the site. This… more
    Curia (08/21/25)
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  • IT Engineer 2 - Scientific Systems

    Fujifilm (Holly Springs, NC)
    …+ Experience in a GMP manufacturing environment. + Understanding of change controls, computer systems validation based on GAMP5, 21CFR/Part 11 compliance ... **Position Overview** The IT Engineer 2 - Scientific Systems manages IT instruments like cell counters and microscopes, ensuring these systems remain validated… more
    Fujifilm (09/03/25)
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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 ... QRM principals and ensuring the integration of Global Quality System requirements into the design + Consult with Network...and visual inspection + Previous experience with Manufacturing Execution Systems . + Previous use of KNEAT - or other… more
    Lilly (10/01/25)
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  • Senior Director, Quality Systems GTS

    BeOne Medicines (Pennington, NJ)
    …Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). Previous experience in a ... experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems , or Master's Degree in Engineering, Computer Science or… more
    BeOne Medicines (10/01/25)
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  • Engineer - Automation Engineering - Historian…

    Lilly (Lebanon, IN)
    …for both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum BS ... systems . * Provide subject matter expertise on data historian systems design, development, installation, testing, validation , and lifecycle support. *… more
    Lilly (09/27/25)
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  • 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 ... systems for the shopfloor and process automation systems and Building Automation System , in close...hardware as required by the job. + Experience with computer systems validation practices (GAMP)… more
    BeOne Medicines (09/12/25)
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  • Engineer - Automation Engineering - PLC and SCADA…

    Lilly (Lebanon, IN)
    …for both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum BS ... in PLC and SCADA system administration (preferably the Rockwell PlantPAX system , Ignition, OPC), knowledge of Microsoft operating systems and experience in… more
    Lilly (09/24/25)
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  • CSV Specialist

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