CSV Engineer (GxP Systems Engineer)

• 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.
• Ensure GMP compliance and inspection readiness.

• Bachelor’s degree in STEM (or related field)
• 4+ years in cGxP environment
• Experience with CSV documentation and lifecycle activities
• Familiarity with QMS, Document Management, ServiceNow
• Experience with KNEAT or similar SDLC tools
• Knowledge of change controls, deviations, and CAPA processes

Preferred Skills:

• Experience with lab instruments (TOC, Bioanalyzers, Spectramax)
• Experience with systems like Chromeleon, LabX
• Background in pharma/biotech or regulated industries
• Experience with data integration and lab connectivity
• Strong communication and ability to work cross-functionally.

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