Process Engineers Singapore

Role Summary

We are seeking a Process Engineer to support the design scale-up commissioning and operation of GMP biologics manufacturing facilities with a strong focus on process engineering equipment integration and cross-functional coordination. The role involves close collaboration with Quality Validation Supply Chain and Operations teams to ensure compliant efficient and scalable manufacturing processes.

Key Responsibilities

Process & Facility Engineering

• Support process design and scale-up activities for monoclonal antibody (mAb) manufacturing facilities including upstream and downstream operations.
• Participate in the design and optimization of 5000L15000L scale production systems ensuring compliance with GMP and regulatory requirements.
• Review equipment-level and plant-level P&IDs ensuring correct interconnections across multiple vendors including CIP and SIP pathways.
• Support engineering change requests assessing technical feasibility and implementation impact.

Equipment & Project Support

• Support FAT SAT commissioning and validation activities for GMP equipment such as bioreactors centrifuges clean utilities depth filtration chromatography and UF/DF skids.
• Coordinate with Engineering Quality and Validation teams during site startup and expansion projects.
• Review under-construction plant designs and assist in identifying process improvements and cost-optimization opportunities.

Warehouse & Material Flow Support

• Support GMP warehouse design activities including material flow personnel flow sampling and dispensing areas and multitemperature storage concepts.
• Assist in evaluation and implementation of Warehouse Management Systems (WMS) and warehouse automation solutions.

Manufacturing Systems & Compliance

• Support and follow defined SAP PP/MM/QM workflows ensuring accurate process execution and material traceability.
• Participate in Change Control Deviation investigation and New Product Introduction (NPI) activities.
• Contribute to risk assessments CAPA discussions and continuous improvement initiatives in a GMP environment.

Operational Excellence

• Support development and monitoring of process KPIs to improve productivity quality and schedule adherence.
• Collaborate cross-functionally to address process bottlenecks schedule risks and operational issues.

Preferred Qualifications & Experience

• Bachelors or Masters degree in Chemical Engineering Biochemical Engineering Biotechnology or related field.
• Experience in pharmaceutical or biologics manufacturing preferably in GMP-regulated environments.
• Hands-on exposure to upstream and/or downstream processing equipment.
• Experience reviewing P&IDs process flow diagrams and equipment specifications.
• Familiarity with CIP/SIP systems clean utilities and aseptic manufacturing concepts.
• Working knowledge of SAP PP/MM/QM or similar ERP systems is a plus.
• Understanding of Change Control Deviations and Validation lifecycle.

Key Skills

• GMP & Regulatory Compliance
• Process Engineering & Scale-Up
• Biologics / mAb Manufacturing
• FAT / SAT / Commissioning Support
• P&ID Review & Equipment Integration
• Cross-functional Coordination
• Continuous Improvement & KPI Tracking