Contract Senior Process Engineer HJO

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

Job Responsibilities

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

Requirements

• Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Mechanical Engineering or a related engineering discipline.
• Minimum 3–5 years of relevant experience within the pharmaceutical / biopharmaceutical industry.
• Pharmaceutical / biopharmaceutical manufacturing experience will be advantageous.
• Hands-on experience in Change Control and Deviation investigation and closure is required.
• Experience in upstream and/or downstream bioprocess operations; downstream / purification experience is highly preferred.
• Good knowledge of biological drug substance manufacturing processes and process equipment.
• Good communication skills with the ability to work effectively across cross-functional teams.