Senior Process Engineer (Pharmaceutical | Contract ) HJO

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Recruit Express Pte Ltd is seeking an engineer to lead quality event investigations, manage change controls, and develop CAPA arising from deviations in biopharmaceutical manufacturing. The role supports commissioning and qualification of new and modified equipment in cell culture and purification/downstream areas, reviews P&IDs and technical drawings, and ensures adherence to cGMP and GEP.

You will coordinate with Manufacturing, Automation, MSAT, Validation and other teams to drive equipment

Qualifications

• Degree in Engineering or related discipline.
• Experience managing Change Controls and Deviation investigations through closure.
• Solid understanding of cGMP and Good Engineering Practices (GEP).

Responsibilities

• Lead Quality Event / Deviation investigations, including timely initiation, root cause analysis, documentation and closure.
• Raise and manage Change Controls relating to equipment and facility modifications.
• Develop and implement CAPA arising from deviation investigations and ensure timely closure.
• Troubleshoot process and production equipment issues and provide engineering support to manufacturing operations.
• Support commissioning and qualification of new and modified equipment within Cell Culture and Purification / Downstream areas.
• Review and execute commissioning and qualification protocols, including IQ, OQ and PQ activities.
• Review engineering documentation including P&IDs, URS, functional specifications and technical drawings.
• Support equipment installation, inspections, FAT and review of vendor/construction turnover packages.
• Work closely with Manufacturing, Automation, MSAT, Validation and other cross-functional teams on equipment improvements and changes.
• Ensure engineering activities comply with cGMP, GEP, EHS and applicable quality requirements.

Skills

Change Controls

Deviation investigations

CAPA

Troubleshooting

Cross-functional coordination

cGMP/GEP knowledge

Education

Bachelor's degree in Engineering

Job description

Job Responsibilities

• Lead Quality Event / Deviation investigations, including timely initiation, root cause analysis, documentation and closure.
• Raise and manage Change Controls relating to equipment and facility modifications.
• Develop and implement CAPA arising from deviation investigations and ensure timely closure.
• Troubleshoot process and production equipment issues and provide engineering support to manufacturing operations.
• Support commissioning and qualification of new and modified equipment within Cell Culture and Purification / Downstream areas.
• Review and execute commissioning and qualification protocols, including IQ, OQ and PQ activities.
• Review engineering documentation including P&IDs, URS, functional specifications and technical drawings.
• Support equipment installation, inspections, FAT and review of vendor/construction turnover packages.
• Work closely with Manufacturing, Automation, MSAT, Validation and other cross-functional teams on equipment improvements and changes.
• Ensure engineering activities comply with cGMP, GEP, EHS and applicable quality requirements.

Requirements

• Degree in Engineering or related discipline.
• 3-5 years of relevant engineering experience within a pharmaceutical or biopharmaceutical manufacturing environment.
• Hands-on experience managing Change Controls and Deviation investigations through closure is required.
• Good knowledge of biological drug substance manufacturing processes and process equipment.
• Strong understanding of cGMP and Good Engineering Practices (GEP).
• Strong troubleshooting, communication and cross-functional coordination skills.