CQV Engineer

6 days ago

Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

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

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