Computer System Validation (CSV) EngineerStaftonic LLC • Los Angeles, CA, US

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Computer System Validation (CSV) Engineer

Staftonic LLC • Los Angeles, CA, US

2 days ago

Job type

Full-time

Job description

Computer System Validation (CSV) Engineer

Location : Los Angeles, California

Long Term Project

Key Responsibilities :

Develop and maintain Design Specifications (DS), IQ / OQ protocols, and Validation Summary Reports (VSRs).
Execute and review validation deliverables for GxP systems, IT applications, and manufacturing automation.
Apply risk-based validation principles per regulatory guidance.
Collaborate with Quality, Engineering, and IT to align on compliance and project goals.
Maintain SOPs and support audit / inspection readiness.

Qualifications :

Bachelor's degree in Engineering, Computer Science, or Life Sciences.

2–10+ years of experience in Computer System Validation within pharma, biotech, or life sciences.

Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and cGMP practices.

Excellent technical writing and documentation skills.

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Validation Engineer • Los Angeles, CA, US

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