Senior Process Engineer (Pharmaceutical | Contract ) #HJO

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.

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Jenalyn Ooi Huai Sian (R1765551)

Recruit Express Pte Ltd

Company Reg. No. 199601303W

EA Licence No. 99C4599