- Singapore
Advanced Manufacturing Tech Solutions Hiring! Full Time Process Engineers - Singapore in - Ricebowl
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Job Description
Responsibilities
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
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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