Contract Senior Process Engineer - Biopharma CAPA & Change

recruit express pte ltd; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Recruit Express Pte Ltd is seeking an experienced quality professional to lead and close deviation investigations, manage change controls, and drive CAPA in a biopharmaceutical manufacturing environment in Singapore.

The role requires hands-on experience with upstream/downstream bioprocess operations, strong cross-functional collaboration, and a solid understanding of cGMP, EHS, and quality systems.

Qualifications

• Degree in chemical/biochemical/biotech or related engineering discipline.
• 3–5 years of pharma/biopharma manufacturing experience preferred.
• Hands-on Change Control and deviation closure experience required.
• Experience in upstream and/or downstream bioprocess operations is highly preferred.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead and manage Quality Events/Deviations with investigation, analysis and closure.
• Raise and manage Change Controls for modifications to manufacturing equipment and facilities.
• Develop and implement CAPA from deviation investigations and ensure timely completion.
• Troubleshoot process and equipment issues; provide technical support to manufacturing operations.
• Support commissioning and qualification of new/modified equipment in Cell Culture and Purification/Downstream areas.
• Draft, review and execute commissioning and qualification protocols and documentation.
• Coordinate with Manufacturing, Automation, MSAT, Validation and Engineering teams on equipment improvements.
• Support Validation activities including IQ/OQ/PQ protocols.
• Ensure timely closure of EHS and Quality investigations and CAPA actions.
• Ensure engineering activities comply with cGMP, GEP, EHS and quality requirements.

Skills

Change Control

Deviation Investigation

Bioprocess Operations

Cross-functional Collaboration

Communication Skills

Education

Bachelor’s in Chemical/Biochemical Engineering

Bachelor’s in Mechanical Engineering

Job description

Recruit Express Pte Ltd is seeking an experienced quality professional to lead and close deviation investigations, manage change controls, and drive CAPA in a biopharmaceutical manufacturing environment in Singapore.

The role requires hands-on experience with upstream/downstream bioprocess operations, strong cross-functional collaboration, and a solid understanding of cGMP, EHS, and quality systems.