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.
Key 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.
Qualifications & Requirements
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