Computer System Validation (CSV) Engineer
Staftonic LLCLos Angeles, CA, United Statesjob_description.job_card.variable_hours_ago
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job_description.job_card.job_descriptionBachelor’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.
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 :
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Validation Engineer • Los Angeles, CA, United States