Role: CSV Engineer (GxP Systems Engineer)Location: United StatesThis opportunity is open only to candidates who are currently authorized to work in the United States.Role Overview:Support validation, delivery, and administration of GxP 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, LogiLab, SoftMax 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.
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