• Automation Engineer 2, CSV

    Fujifilm (Holly Springs, NC)
    …Visit: https://www.fujifilm.com/us/en/about/region/careers **Job Description** **What You'll Do** + Ensures that Computer System Validation is performed to a ... summary reports) + Helps to assess the impact of Computer System modifications through the change control...the change control process + Helps to maintain the validation status of DSM Automation Computerized Systems more
    Fujifilm (11/04/25)
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  • Scientist II or III - Analytical Chemist Metrology…

    Parexel (Raleigh, NC)
    …and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications -** ... or other specialized computerized systems ** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of… more
    Parexel (11/08/25)
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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 (12/12/25)
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  • Manufacturing Execution System (MES) -Lead

    J&J Family of Companies (Wilson, NC)
    …, internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** Computer System Validation (CSV) **Preferred Skills:** ... site's Kroeber PAS-X MES, including MBR design, vendor management, production, validation and development systems , system standards, and interfaces to DCS &… more
    J&J Family of Companies (11/05/25)
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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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  • System Administrator - Senior Associate

    Amgen (Holly Springs, NC)
    …for SDLC methodologies and 21 CFR Part 11. + General experience with computer validation and change control methodology. + Experience with computerized ... team. Join us and transform the lives of patients while transforming your career. System Administrator - Senior Associate **What you will do** Let's do this. Let's… more
    Amgen (11/26/25)
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  • Staff QA Engineer

    ThermoFisher Scientific (Greenville, NC)
    Validation related deviations and discrepancies. + Process Validation (PV), Cleaning Validation , and Computer System related protocols and reports. + ... Description** The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory… more
    ThermoFisher Scientific (10/02/25)
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  • Senior Engineer, Application Development…

    Cardinal Health (Raleigh, NC)
    …You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team ... design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical requirements… more
    Cardinal Health (10/10/25)
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  • Staff Software Systems Engineer, Behavior…

    General Motors (Raleigh, NC)
    **Job Description** **Role:** As a Staff Software Systems Engineer on the Behavior Validation team within the AV organization, you will play a critical role in ... experience in system engineering and requirements management including system analysis, requirements authoring, test generation, and validation activities… more
    General Motors (12/12/25)
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  • IT Systems Manager

    Insight Global (Clayton, NC)
    systems management within a cGMP pharmaceutical environment. -Proven expertise in computer system validation (CSV), data integrity, and compliance ... Job Description Insight Global is seeking an IT Systems Manager for a pharmaceutical client in the Raleigh area. The IT Systems Manager will lead and manage… more
    Insight Global (12/14/25)
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