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Computer System Validation Engineer

Katalyst Healthcares & Life Sciences

  • New Wilmington, PA
  • 30+ days ago

    Highlights

    Job Summary: Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. Roles & Responsibilities: Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, and ITIL.

    Numbers & Facts

    LocationNew Wilmington, PA

    Description

    Job Summary:
    • Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems.
    • Strong experience in CSV processes, regulatory frameworks, validation documentation, and exposure to clinical and regulatory domains.
    Roles & Responsibilities:
    • Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, and ITIL.
    • Ensure audit and inspection readiness.
    • Conduct periodic reviews, access roster reviews, and audit trail reviews.
    • Manage deviations, CAPA processes, SOP, and policy compliance.
    • Author and review URS / FS documents, validation protocols, validation plans & reports, and final summary reports.
    • Perform risk-based validation and testing aligned with CSA (Computer Software Assurance).
    • Support validation lifecycle from planning to execution and closure.
    • Work with platforms such as Veeva Vault Suite, LabWare LIMS, SAP (GxP modules), and BIOVIA Electronic Lab Notebook.
    • Collaborate with teams across Biostatistics, Clinical & Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, Manufacturing, Quality, and TechOps.
    Education & Experience:
    • 8–10 years of experience in Computer System Validation (CSV).
    • Strong knowledge of GxP regulations, validation frameworks, GAMP 5, and CSA principles.
    • Experience with CAPA, deviation management, SOP, and policy compliance.
    • Strong documentation and validation lifecycle experience.
    • Good understanding of life sciences domain processes.

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