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Katalyst Healthcares & Life Sciences

Computer System Validation Engineer

Pay: Not specified

Posted: 2 weeks ago

Location: Wilmington, DE (Onsite)

Last Updated: 2 weeks ago

Hours: Full-Time

Expires: 10/1/2026

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What they do

A Validation Engineer evaluates and maintains machinery and equipment used in manufacturing, and supervises workers that use and repair the machines.

$99,941 / year median in Delaware

-4% projected decline

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Job Description

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