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Computer System Validation Engineer

7 years

0 Lacs

Hyderabad Telangana India

Posted:1 day ago| Platform: Linkedin logo

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Skills Required

support documentation compliance trackwise lims sap data integrity zones

Work Mode

Remote

Job Type

Contractual

Job Description

Role: CSV Engineer Location: Remote (Site - Hyderabad) Type: Contract (Long Term) Experience Required: 4–7 years 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 Show more Show less

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