
CSV Engineer
17 hours ago
Computer System Validation (CSV) Engineer
Role: CSV Engineer
Location: Gurugram
Experience: 2–5 Years
Key Responsibilities:
- Develop & execute validation strategies/plans for computerized systems.
- Prepare validation docs: URS, FS, Risk Assessments, VP, IQ/OQ/PQ, Traceability Matrix.
- Ensure compliance with FDA, EMA, GAMP 5, 21 CFR Part 11.
- Validate systems (LIMS, MES, ERP, QMS, SCADA, PLCs, custom apps).
- Perform change control, impact assessments & data integrity compliance.
- Collaborate with IT, QA, Manufacturing; provide CSV training.
Requirements:
- Bachelor's in Engineering/CS/Life Sciences.
- 2–5 yrs CSV experience in pharma/biotech/medical devices.
- Knowledge: GAMP 5, SDLC, Part 11, Annex 11.
- Strong documentation & project management.
- Tools: MS Office, ValGenesis/MasterControl (plus).
- CSV/GxP certifications preferred.
Job Type: Full-time
Work Location: In person
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