Computer System validation Engineer
Wilmington, DE - USA
Job Summary
Hi
Title:Computer System validation Engineer
Compute System Validation(CSV) with R&D Knowledge
Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelors in Pharmacy
Experience: Over 8 years of overall experience with at least 5 years of experience in Computer System validation for GxP system
Knowledge Experience and Skills:
CORE CSV
21 CFR Part 11/820 GxP GAMP 5 SOX EU Annex 11/22 ISO 9001 ITIL EU Anness 22 ISO 9001 ITIL Audit/inspection readiness periodic reviews access roster and audit trail reviews Deviation/CAPA management SOP/policy compliance processes
Authoring of URS/FS protocols final reports validation plan/report
High-level understanding of Veeva Vault suits
Risk-based testing aligned to CSA fundamentals