Process Engineer – GMP Biologics Manufacturing (Singapore)

About the role

We are looking for a Process Engineer to support the design, scale‑up, commissioning and operation of GMP biologics manufacturing facilities in Singapore. The role works closely with Quality, Validation, Supply Chain and Operations to deliver compliant, efficient and scalable processes.

Key responsibilities

• Support process design and scale‑up for monoclonal antibody (mAb) manufacturing, covering upstream and downstream operations.
• Participate in the design and optimisation of 5,000 L–15,000 L production systems, ensuring GMP and regulatory compliance.
• Review equipment‑level and plant‑level P&IDs, verify interconnections across multiple vendors, including CIP and SIP pathways.
• Assist with engineering change requests, FAT, SAT, commissioning and validation of GMP equipment such as bioreactors, centrifuges, clean utilities, depth‑filtration, chromatography and UF/DF skids.
• Support GMP warehouse design, material flow, multi‑temperature storage and evaluation of Warehouse Management Systems and automation solutions.
• Follow SAP PP/MM/QM workflows, contribute to Change Control, deviation investigations, NPI activities and continuous improvement initiatives.
• Develop and monitor process KPIs, collaborate cross‑functionally to resolve bottlenecks and schedule risks.

Required profile

• Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology or related field.
• Experience in pharmaceutical or biologics manufacturing, preferably in a GMP‑regulated environment.
• Hands‑on exposure to upstream and/or downstream processing equipment.
• Familiarity with reviewing P&IDs, process flow diagrams and equipment specifications.

Required skills

• GMP and regulatory compliance
• Process engineering and scale‑up
• P&ID review
• CIP/SIP systems
• Bioreactors, centrifuges, clean utilities, depth filtration, chromatography, UF/DF skids
• SAP PP/MM/QM (or similar ERP)
• Change Control, deviation handling and validation lifecycle
• Warehouse Management Systems (WMS) and automation concepts