• Cybersecurity Specialist (Healthcare/Medical…

    Abbott (Lake Forest, IL)
    …in ISO13485, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA ... **Key Responsibilities also include:** + Effectively assess regulatory and validation requirements for computer systems ... within organization + Identify and develop all required computer system validation deliverables including… more
    Abbott (08/01/25)
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  • Sr Business Analyst, Selution

    Cordis (Irvine, CA)
    …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... (PLM). You'll map business processes end-to-end, translate them into system requirements, and lead continuous improvement initiatives that boost productivity,… more
    Cordis (07/30/25)
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  • Computer Systems Validation

    Unither Pharmaceuticals (Rochester, NY)
    Computer Systems Validation Specialist Who...In depth understanding and knowledge of successfully validating a computer system to meet all FDA ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
    Unither Pharmaceuticals (08/08/25)
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  • Senior Computer Systems

    Catalent Pharma Solutions (Harmans, MD)
    **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE… more
    Catalent Pharma Solutions (08/08/25)
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  • Sr. Engineer Computer System

    J&J Family of Companies (Raritan, NJ)
    …Responsibilities:** + Provide preparation, generation and flawless execution of Computer System Validation for GMP Systems and Processes. + Collaborate ... searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) to...managing Validation activities, with a focus on computer systems , software, as well as GMP… more
    J&J Family of Companies (08/09/25)
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  • Computer System Validation

    Abeona (Cleveland, OH)
    Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... through commercial production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems in alignment… more
    Abeona (05/13/25)
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  • Computer Systems Validation

    PCI Pharma Services (Bedford, NH)
    …team. In this role, you'll take the lead in developing and executing validation strategies for GxP computer systems -ensuring everything from equipment ... regulatory and performance standards. **What You'll Do:** + Lead validation activities throughout the computer system...assessments, and execute validation protocols for GxP systems and infrastructure. + Ensure compliance with FDA more
    PCI Pharma Services (08/08/25)
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  • Computer Systems Validation

    Charles River Laboratories (Wayne, PA)
    …protocols]. + Write or assist in the writing of SOPs as they pertain to computer system validation and data integrity. + Collaborate with cross functional ... / assist in the preparation of clear and concise validation deliverables for computerized systems , including ...related field. + _Experience:_ 1-3 years of experience in computer system validation within a… more
    Charles River Laboratories (08/08/25)
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  • Validation Specialist - Computer

    Kedrion Biopharma (Melville, NY)
    …audit trails, access controls, data migration, and backup._ + _Own and maintain system validation procedures and documentation across the site._ + _Partner with ... opportunity to make a real impact by shaping our validation program in alignment with FDA , EU,...GAMP 5 standards._ **_Job Role and Responsibilities_** + _Lead validation projects for GxP systems -authoring and executing… more
    Kedrion Biopharma (08/08/25)
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  • Senior Validation Specialist-…

    Regeneron Pharmaceuticals (Cambridge, MA)
    …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
    Regeneron Pharmaceuticals (07/26/25)
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