CQV Engineer – Laboratory Systems

1 week ago


Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time
Roles & Responsibilities

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

Tell employers what skills you have

Test Validation
Computer Validation
GMP
Microbiology
Validation testing
Process Validation
Computer System Validation
Compliance
Life Sciences
Laboratory
Audit
Analytical Instruments

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