• Senior Manager, IT - GxP Computer…

    Bristol Myers Squibb (Indianapolis, IN)
    …team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
    Bristol Myers Squibb (07/14/25)
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  • Associate Director, GxP Systems

    Vera Therapeutics (Brisbane, CA)
    …gathering, configuration, testing, and deployment. * Partner with QA to develop and maintain Computer System Validation (CSV) documentation per GAMP5 and 21 ... and will be responsible for leading the implementation, validation , and support of GxP -regulated systems...assessments, change control documentation, testing, and release planning for GxP system . * Provide IT support for… more
    Vera Therapeutics (06/25/25)
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  • Quality Specialist, DI & GxP Systems…

    Catalent Pharma Solutions (St. Petersburg, FL)
    …+ Pharmaceutical and/or life sciences experience including Computer System Validation , 21 CFR Part 11 and general GxP experience preferred. + ... **Quality Specialist, Data Integrity & GxP Systems Compliance** **Position Summary** Catalent,...St. Petersburg, FL location. **The Role** + Enforce Computerized System Validation (CSV) guidelines, policies, and procedures… more
    Catalent Pharma Solutions (05/22/25)
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  • Computer Systems Validation…

    PCI Pharma Services (Bedford, NH)
    …+ Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems from supporting GxP manufacturing and QC operations ... with departments inside the organization to maintain and improve computer system validation processes to...of computerized systems . + Author and review validation documents (IQ/OQ/PQ) supporting GxP computerized … more
    PCI Pharma Services (06/07/25)
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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 ... execute validation deliverables for new and existing GxP systems in alignment with regulatory guidelines...11, EU Annex 11, GAMP 5). . Partner with system owners, QA, IT, and vendors to define User… more
    Abeona (05/13/25)
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  • Validation Specialist - Computer…

    Kedrion Biopharma (Melville, NY)
    …with FDA, EU, and GAMP 5 standards._ **_Job Role and Responsibilities_** + _Lead validation projects for GxP systems -authoring and executing protocols and ... audit trails, access controls, data migration, and backup._ + _Own and maintain system validation procedures and documentation across the site._ + _Partner with… more
    Kedrion Biopharma (05/06/25)
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  • Sr. Director - Computer System…

    Lilly (Indianapolis, IN)
    …people around the world. **Responsibilities** : The Senior Director, Global Process Owner for Computer System Validation (CSV), as a leader within the Global ... and maintain the global quality system for computer system validation , including Global...other Life Science-related field. + 5+ years experience with GxP and quality management systems , including experience… more
    Lilly (07/16/25)
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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 (06/25/25)
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  • Senior Engineer, IT Computer System…

    Bristol Myers Squibb (Devens, MA)
    …personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Senior Engineer - IT Computer System Validation , Cell Therapy Devens role will ... System (Celabs) is preferred. + Knowledge of various GxP supporting systems , such as Quality Management...quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems… more
    Bristol Myers Squibb (07/16/25)
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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 (05/10/25)
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