CQV Validation Engineer – GMP Pharma Facilities

JDA WMS PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

JDA WMS PTE. LTD. is seeking a Validation Engineer in Singapore to drive CQV activities for GMP-regulated pharma and biopharma projects.

You will validate equipment, utilities, and systems, prepare validation documentation, and ensure compliance with GMP, GAMP 5, and FDA 21 CFR Part 11. You will coordinate with project engineers, QA, clients, contractors, and vendors, perform risk assessments, CAPA, and support FAT/SAT during commissioning.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
• 3–5 years of validation/CQV experience within the pharmaceutical or biopharmaceutical industry.
• Must have working experience in the construction industry.
• Good knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, EU GMP, and data integrity requirements.
• Experience with validation of equipment, utilities, cleanrooms, HVAC, water systems, or computerized systems will be an advantage.
• Strong documentation, analytical, and problem-solving skills.
• Excellent communication and coordination skills with the ability to work effectively in a multidisciplinary project environment.
• Able to communicate in Mandarin to liaise with Mandarin-speaking clients, contractors, suppliers, and project stakeholders where required.

Responsibilities

• Execute CQV activities for GMP-regulated facilities.
• Prepare, review, and maintain validation documentation including IQ/OQ/PQ protocols and reports.
• Validate equipment, utilities, facilities, and computerized systems per GMP and regulatory standards.
• Coordinate with project engineers, QA, clients, contractors, and vendors to meet schedules.
• Conduct risk and impact assessments, deviations, and implement CAPA.
• Support FAT, SAT, commissioning and qualification for new/modified systems.
• Ensure validation records are complete and data integrity compliant.
• Provide technical support across design, construction, commissioning, and validation phases.

Skills

Analytical skills

Problem solving

Communication skills

Mandarin communication

Education

Bachelor's degree in Engineering/Life Sciences/Pharmaceutical Sciences

Tools

GMP knowledge

GAMP 5

FDA 21 CFR Part 11

IQ/OQ/PQ protocols

Validation testing

Job description

JDA WMS PTE. LTD. is seeking a Validation Engineer in Singapore to drive CQV activities for GMP-regulated pharma and biopharma projects.

You will validate equipment, utilities, and systems, prepare validation documentation, and ensure compliance with GMP, GAMP 5, and FDA 21 CFR Part 11. You will coordinate with project engineers, QA, clients, contractors, and vendors, perform risk assessments, CAPA, and support FAT/SAT during commissioning.