
CQV Engineer – Laboratory Systems
2 weeks ago
Overview
We are seeking a CQV Engineer with strong experience in Computer System Validation (CSV) for laboratory and analytical equipment within GMP-regulated environments. The ideal candidate will bring expertise in 21 CFR Part 11, audit trails, and data integrity controls, with a solid understanding of system interfaces between instruments, PCs, networks, and enterprise systems.
Responsibilities- Lead CSV activities for laboratory/analytical equipment, ensuring compliance with cGMP, 21 CFR Part 11, and data integrity requirements.
- Draft and execute validation deliverables (URS, Risk Assessments, Test Scripts, IQ/OQ/PQ, Traceability).
- Assess and implement audit trail review requirements and system access controls.
- Support integration of instruments with PCs, networks, and enterprise systems.
- Prepare and review SOPs, validation documentation, and lifecycle deliverables.
- Collaborate with QA, QC, IT, and system owners to ensure compliant system deployment.
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
- 5–10 years of hands-on CSV experience in analytical instruments.
- Strong knowledge of 21 CFR Part 11, audit trails, data integrity, Windows OS.
- Exposure to microbiology analytical equipment is advantageous.
- Experience with Kneat validation management system preferred.
- Excellent problem-solving, documentation
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