Job Description
Role: CSV Engineer (Gx P Systems Engineer)Location: United States This opportunity is open only to candidates who are currently authorized to work in the United States.Role Overview: Support validation, delivery, and administration of Gx P laboratory and enterprise computerized systems.Work within the Digital Quality team to ensure system compliance, performance, and lifecycle management.Key Responsibilities: Manage lifecycle of lab systems (HIAC, FTIR, TOC, Bioanalyzers, Sequencers) and enterprise systems (Chromeleon, Logi Lab, Soft Max Pro).
Translate business and technical requirements into digital lab system solutions.Lead and execute Computer System Validation (CSV) activities (URS, FRS, IQ/OQ/PQ, etc.).
Author and maintain validation and compliance documentation.Act as system administrator for QC lab systems.Troubleshoot system issues and support incident resolution.Conduct periodic reviews, audit trail reviews, and user access reviews.Ensure GMP compliance and inspect...