Senior CSV Engineer

Job Summary

We are seeking a Senior CSV Engineer with strong experience in laboratory equipment qualification, CSV, and LabVantage LIMS within a GxP-regulated environment. The ideal candidate will have hands-on experience with Climet/environmental monitoring equipment, SAT, IQ/OQ, LIMS integrations, and validation documentation.

Responsibilities

• Lead CSV and equipment qualification activities for laboratory instruments integrated with LabVantage LIMS.
• Execute SAT, IQ, OQ, and vendor-provided qualification protocols.
• Develop/update URS, risk assessments, test scripts, traceability, and validation summaries.
• Test LIMS interfaces and data flows to ensure accurate and reliable data transfer.
• Review vendor documentation and identify gaps, deviations, and exceptions.
• Ensure compliance with GxP, 21 CFR Part 11, data integrity, CSV/CSA, and change control requirements.
• Document test results and support deviation, investigation, and CAPA activities.
• Collaborate with Laboratory, Quality, IT, Validation teams, and equipment vendors.
• Ensure validation packages are complete, traceable, and audit-ready.

Requirements

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 5+ years of CSV, equipment qualification, or validation experience in regulated life sciences.
• 2–3+ years of laboratory equipment qualification with LIMS; LabVantage experience strongly preferred.
• Hands-on experience with SAT, IQ/OQ, URS, risk assessments, test scripts, and traceability.
• Strong knowledge of GxP, CSV/CSA, data integrity, 21 CFR Part 11, and validation lifecycle.
• Experience testing LIMS interfaces and data flows.
• Strong troubleshooting, documentation, and stakeholder-management skills.