Role: Senior Computer System Validation (CSV) Engineer GxP / PharmaceuticalLocation: Wilmington, DENumber of Positions: 3Role Descriptions:Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelors in PharmacyExperience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP systemKnowledge, Experience and Skills: CORE CSV21 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 processesAuthoring of URS/FS, protocols, final reports, validation plan/reportHigh-level understanding of Veeva Vault suitsRisk-based testing aligned to CSA fundamentals AND R&DHigh-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP
Not specified in the original listing.
Not specified in the original listing.
