CQV Validation Engineer – Biopharma Utilities

PROCESS ENGINEERING SPECIALISTS PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Process Engineering Specialists is seeking experienced Validation Engineers to join our Life Sciences team in Singapore on permanent roles. Strong CQV experience across filling lines, benchtop equipment, utilities, and HVAC/clean air devices is preferred.

PES operates globally and values compliant, high-quality validation delivery. You will review and approve C&Q plans, provide quality oversight for GMP facilities and systems, and ensure adherence to regulatory standards.

Qualifications

• Experience in biopharmaceutical GMP plant validation, CQV activities.
• Proven ability to review C&Q plans and GxP SOPs/records.
• Strong documentation and regulatory compliance skills.

Responsibilities

• Review and approve C&Q plans/protocols/reports and GxP SOPs/records.
• Provide quality oversight to validate GMP plant facilities, utilities and equipment, control systems, and computerized systems.
• Review validation life-cycle documents during IQ/OQ/PQ phases (e.g., pre and post-execution commissioning/qualification plans and test specs).
• Ensure documents comply with quality standards and regulatory requirements.
• Review engineering change control to evaluate validation/quality impact(s).
• Support in the resolution of validation deviations and approvals.
• Participate in qualification coordination meetings to ensure correct event sequence in compliance.

Skills

CQV experience

GxP knowledge

Quality oversight

Regulatory compliance

Job description

Process Engineering Specialists is seeking experienced Validation Engineers to join our Life Sciences team in Singapore on permanent roles. Strong CQV experience across filling lines, benchtop equipment, utilities, and HVAC/clean air devices is preferred.

PES operates globally and values compliant, high-quality validation delivery. You will review and approve C&Q plans, provide quality oversight for GMP facilities and systems, and ensure adherence to regulatory standards.