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Katalyst CRO Linkedin · Posted 8d ago

Computer System Validation Engineer

New Wilmington

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Indexed 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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