K
Katalyst CRO
Computer System Validation Engineer
Skills
RAIITILCompliance
1 month ago
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Important information
Contract type:
Freelance / Contract
Location:
Wilmington, DE, USA
Work mode:
Onsite
Published on:
12 September 2026
What they need
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
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