CSV Laboratory Engineer

About the role

The CSV Laboratory Engineer will ensure that all laboratory computerized systems meet regulatory, quality, and data‑integrity standards. You will lead validation activities, support system upgrades, and work closely with QC, IT, and QA teams to keep the laboratory in an audit‑ready state.

Key responsibilities

• Draft and review URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices, validation summary reports, and change controls.
• Verify that all validation deliverables comply with GMP, GAMP 5, ALCOA+, and internal quality standards.
• Maintain the validated state of laboratory systems through periodic reviews, re‑qualification, and change management.
• Support implementation, qualification, and lifecycle management of analytical laboratory computerized systems.
• Troubleshoot CSV‑related issues and provide technical guidance to QC laboratory teams.
• Coordinate with vendors and cross‑functional teams to ensure smooth transitions without compromising functionality or compliance.

Required profile

• Degree in Engineering, Computer Science, Life Sciences or a related discipline.
• 3–5 years of CSV experience, preferably in GMP‑regulated pharmaceutical, biopharmaceutical or medical‑device laboratories.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, data‑integrity principles and GMP requirements.
• Proven experience validating laboratory computerized systems.
• Excellent documentation and communication skills.
• Ability to lead cross‑functional validation initiatives.

Required skills

• GAMP 5
• FDA 21 CFR Part 11
• Annex 11
• Data‑integrity principles (ALCOA+)
• GMP compliance
• Validation of laboratory computerized systems (URS, IQ, OQ, PQ, traceability matrix, change control)
• Analytical laboratory instrumentation knowledge

What we offer

• Generous leave policy
• Comprehensive medical and dental coverage
• Professional development programs and continuous learning resources
• Inclusive culture that values innovation, collaboration and diverse perspectives