Senior Computer System Validation Engineer - GxP Compliance
Job in
Wilmington, New Castle County, Delaware, 19894, USA
Listed on 2026-10-07
Listing for:
JobDiva, Inc.
Full Time
position Listed on 2026-10-07
Job specializations:
-
IT/Tech
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Roles & Responsibilities :
- 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
- High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP
Education & Experience :
- 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
This posting is for the Senior Computer System Validation Engineer - GxP Compliance role at Job Diva, Inc., based in Wilmington, DE, United States.
Position Requirements
10+ Years
work experience
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