Biopharma Process Engineer – Deviation, CAPA & Change Control

Recruit Express Pte Ltd.; Singapore; On-site; SGD 81,000 - 97,000; Full time

Job summary

Recruit Express Pte Ltd is hiring a Process Engineer for a 1 year contract in the North region of Singapore, offering up to SGD 8,000 per month. The role focuses on leading Quality Event (Deviation) processes, Change Control, and CAPA with cross-functional teams including MSAT, Automation, and Engineering.

The candidate should have a degree in Life Sciences or Engineering and at least 5 years of bioprocess operations experience, with strong knowledge of deviations and regulatory requirements.

Qualifications

• Min degree in Life Sciences/Engineering with at least 5 years in upstream/downstream bioprocess operations and deviation experience.
• Experience in deviation and change control in biopharma industry.
• Ability to lead Quality Events and CAPA to closure.
• Strong cross-functional collaboration with MSAT, Automation, and Engineering teams.
• Familiarity with IQ/OQ/PQ and vendor turnover activities.

Responsibilities

• Raise and lead Quality Event (Deviation) processes and ensure timely creation, analysis and closure of events.
• Raise and lead Change Control for equipment/facility changes.
• Own and implement CAPAs identified from deviation investigations.
• Troubleshoot equipment and perform preliminary troubleshooting with Maintenance.
• Coordinate with Automation, MSAT, and manufacturing for improvements.
• Review vendor turnover, construction turnover, and functional specifications.
• Involve software FAT with PCS7, if applicable; participate in commissioning and qualification of new/modified equipment.
• Assist Validation with IQ/OQ/PQ execution.

Skills

Quality Event Management

Deviation Handling

Change Control

CAPA

Cross-functional collaboration

PCS7

IQ/OQ/PQ

Education

Degree in Life Sciences/Engineering

Tools

PCS7

Job description

Recruit Express Pte Ltd is hiring a Process Engineer for a 1 year contract in the North region of Singapore, offering up to SGD 8,000 per month. The role focuses on leading Quality Event (Deviation) processes, Change Control, and CAPA with cross-functional teams including MSAT, Automation, and Engineering.

The candidate should have a degree in Life Sciences or Engineering and at least 5 years of bioprocess operations experience, with strong knowledge of deviations and regulatory requirements.