Computer System Validation Engineer
Share Contractual Wilmington, DE
Overview:
Hi,
Title: Computer System Validation Engineer
Compute System Validation (CSV) with R&D Knowledge Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor's 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
Skills: N/A
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