CQV Engineer – Laboratory Systems

ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A technology solutions firm in Singapore is looking for a CQV Engineer with extensive experience in Computer System Validation (CSV) for laboratory and analytical equipment. The ideal candidate will ensure compliance with GMP regulations, 21 CFR Part 11, and manage validation documentation effectively. This role requires 5-10 years of relevant experience and expertise in audit trails and data integrity controls.

Qualifications

• 5–10 years of hands-on CSV experience in analytical instruments.
• Strong knowledge of 21 CFR Part 11, audit trails, data integrity.
• Exposure to microbiology analytical equipment is advantageous.

Responsibilities

• Lead CSV activities for laboratory/analytical equipment.
• Draft and execute validation deliverables.
• Collaborate with QA, QC, IT, and system owners.

Skills

Computer System Validation

Data Integrity

Audit Trails

Problem Solving

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences

Tools

Kneat validation management system

Job description

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.

Qualifications

• 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!