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 5,000L–15,000L 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 multi‑temperature 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

• Bachelor's or Master's 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