Computer System Validation Engineer- Pharma

Position: Offshore CSV Engineer Experience Required: 4–7 years Location: Offshore (India – remote role) Client: US-based Pharmaceutical Company Type: Full-Time Job Summary: The candidate will support the validation of GxP-regulated computerized systems, working remotely with QA and IT teams based in the US. This includes preparing validation documentation, executing protocols, and ensuring compliance with FDA and EU regulatory standards. Key Requirements: Hands-on experience in Computer System Validation (CSV) in the pharma/life sciences domain Proficiency with validation lifecycle documents (URS, IQ, OQ, PQ, etc.) Familiarity with TrackWise, LIMS, SAP, or similar systems Strong knowledge of FDA 21 CFR Part 11, Annex 11, GAMP 5, and data integrity requirements Comfortable collaborating across time zones with US-based stakeholders Email me resume to pavani@intellectt.com Show more Show less