Computer System Validation Engineer

CSV Consultant

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 and responsibilities include:

• Performing 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.
• Ensuring audit and inspection readiness.
• Conducting periodic reviews, access roster reviews, and audit trail reviews.
• Managing deviations, CAPA processes, SOP, and policy compliance.
• Authoring and reviewing URS / FS documents, validation protocols, validation plans & reports, and final summary reports.
• Performing risk-based validation and testing aligned with CSA (Computer Software Assurance).
• Supporting validation lifecycle from planning to execution and closure.
• Working with platforms such as Veeva Vault Suite, Lab Ware LIMS, SAP (GxP modules), and BIOVIA Electronic Lab Notebook.
• Collaborating with teams across Biostatistics, Clinical & Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, Manufacturing, Quality, and Tech Ops.

Education and experience required:

• 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.