Process Engineer | Biopharmaceutical Manufacturing & GMP #HDC1

Drive Process Excellence Across Critical Biopharmaceutical Operations We are seeking an experienced  Process Engineer  to support engineering and manufacturing activities within a  cGMP-regulated biopharmaceutical environment . This role will work closely with Process Engineering, Manufacturing, MSAT, Automation, Maintenance and Validation teams to support  deviation investigations, change controls, equipment commissioning, qualification and continuous improvement initiatives  across Cell Culture and Downstream/Purification operations. If you have hands-on experience supporting pharmaceutical or biopharmaceutical manufacturing and are confident managing technical investigations and engineering changes, this role offers an opportunity to contribute to complex manufacturing projects and critical process improvements. What You’ll Be Responsible For Lead and manage  Quality Events / Deviation investigations , ensuring timely creation, analysis, corrective actions and closure.

Lead  Change Controls  relating to equipment and facility modifications, upgrades and improvements.

Own and implement  CAPA projects  arising from deviation investigations.

Troubleshoot equipment issues and support fault-finding when systems operate outside expected parameters.

Ensure timely completion of EHS and Quality investigations, CAPA activities and associated actions.

Represent Process Engineering in cross-functional technical meetings and initiatives.

Work closely with  Automation, Manufacturing and MSAT teams  to implement improvements and engineering changes.

Collaborate with engineering consultants and project teams on new and modified equipment.

Review technical documentation including  P&IDs, URS, functional specifications, drawings and equipment turnover packages .

Participate in equipment installation inspections and vendor/construction turnover activities.

Participate in software FAT activities, including  PCS7 , where applicable.

Support and participate in  Commissioning & Qualification (C&Q)  activities for new and modified equipment within Cell Culture and Downstream/Purification areas.

Review and execute C&Q documentation and support qualification activities including  IQ, OQ and PQ .

Work towards delivering projects and engineering activities  right first time , while maintaining applicable GMP, EHS and engineering standards.

Perform other engineering duties and projects as assigned.

What We’re Looking For Degree or relevant qualification in  Engineering, Bioprocessing or a related discipline .

3–5+ years of relevant experience  in upstream/downstream bioprocess operations or equipment engineering within the pharmaceutical or biopharmaceutical industry.

Experience supporting  cGMP manufacturing operations  in a pharmaceutical or biopharmaceutical environment.

Strong experience in  Deviation / Quality Event investigation and Change Control management .

Knowledge of biological drug substance manufacturing processes;  downstream/purification experience is highly advantageous .

Understanding of equipment commissioning, qualification stages and associated process activities.

Strong knowledge of  cGMP and Good Engineering Practices (GEP) .

Familiarity with biopharmaceutical facility design principles and engineering standards.

Knowledge of sanitary design requirements for biopharmaceutical manufacturing equipment.

Strong troubleshooting, analytical and problem-solving capabilities.

Good written and verbal communication skills, with the ability to work effectively across technical and cross-functional teams.

Why Consider This Opportunity? Take on a hands-on engineering role within a  specialised biopharmaceutical manufacturing environment , supporting critical equipment, process improvements, deviations, change controls and qualification activities. You’ll gain exposure across  Cell Culture, Downstream/Purification, C&Q, GMP investigations and cross-functional engineering projects , making this a strong opportunity for an engineer looking to deepen their expertise in biopharmaceutical manufacturing. Interested candidates may submit their updated CV to  leonleong@recruitexpress.com.sg . EA Personnel:  Leon Leong De Cong EA Registration No.:  R1551708 Recruit Express Pte Ltd EA License No.:  99C4599