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Galaxy i Technologies, Inc.

Senior Computer System Validation (CSV) Engineer

Pay: Not specified

Posted: 4 days ago

Location: Wilmington, DE (Onsite)

Last Updated: 2 days ago

Hours: Full-Time

Expires: 11/30/2026

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Job Description

Job Title :

Senior Computer System Validation (CSV)

Engineer Location :

Wilmington, DE JD :

Qualification:

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

Knowledge, Experience and Skills:

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CORE CSV

 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 } AND { R D  High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R D AI GxP