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. Interested candidates are invited to email your resume to: jen.ooi@recruitexpress.com.sg Jenalyn Ooi Huai Sian (R1765551) Recruit Express Pte Ltd Company Reg. No. 199601303W EA Licence No. 99C4599