Contract Senior Process Engineer (Pharma | Up to $8000) #HJO

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 67,000 - 112,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD invites a seasoned quality engineer to lead deviation investigations, manage CAPA actions and ensure timely closure within our biopharmaceutical manufacturing operations in Singapore.

You will raise and manage change controls for equipment and facilities, support commissioning/qualification (IQ/OQ/PQ), troubleshoot process and equipment issues, and collaborate with Manufacturing, Automation, MSAT, Validation and Engineering to drive process improvements while upholding

Qualifications

• Minimum 3–5 years of relevant experience in the pharmaceutical/biopharmaceutical industry.
• 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.

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.

Skills

Quality events

CAPA implementation

Deviation investigation

Cross-functional collaboration

Troubleshooting

Education

Chemical Engineering

Biochemical Engineering

Biotechnology

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.