Computer System Validation Engineer
Job in
Wilmington, New Castle County, Delaware, 19805, USA
Listed on 2026-08-16
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-08-16
Job specializations:
-
IT/Tech
Information Security & Data Protection, Cybersecurity
Job Description & How to Apply Below
Job Title
Roles and 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 and 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
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×