Computer System Validation Engineer
Katalyst CRO · New Wilmington, PA · 3 mo ago
On-siteEngineeringContract
Job Summary
An experienced CSV Consultant required 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.
- 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.