Process Engineer

Position Overview The Process Engineer is responsible for supporting the introduction, qualification, and commercialization of new products and processes within the manufacturing facility. This role ensures production readiness through process assessment, material planning, system setup, and manufacturing execution support, while maintaining compliance with quality and operational requirements. Key Responsibilities Process Assessment & Manufacturing Readiness - Assess QC buffer requirements and manufacturing feasibility for products to be produced in Singapore. - Evaluate process capabilities, equipment suitability, and manufacturing constraints to support local production implementation. - Perform Facility Fit Assessments (FFA) to ensure product and process compatibility with existing manufacturing infrastructure. Process Qualification (PQ) Support - Coordinate and support Process Qualification (PQ) activities to ensure manufacturing readiness. - Raise requests for raw materials required for qualification runs and production startup. - Ensure proper segregation, identification, and management of raw materials in accordance with quality and regulatory requirements. - Work closely with Supply Chain, Warehouse, Quality, and Production teams to ensure material availability for qualification activities. Manufacturing Documentation Development - Create and maintain Production Instructions (PIs) to support manufacturing operations. - Develop and manage Bills of Materials (BOMs) to ensure accurate material planning and production execution. - Review documentation accuracy and alignment with product specifications and manufacturing requirements. MES & System Implementation - Configure and set up products, processes, and workflows within the Manufacturing Execution System (MES). - Verify MES master data, process routes, and system parameters to support production and qualification activities. - Troubleshoot and resolve MES-related issues during implementation and startup phases. Cross-Functional Collaboration - Collaborate with Quality, Supply Chain, Production, Engineering, and Regulatory teams to ensure smooth product transfers and launches. - Support investigations, change controls, and continuous improvement initiatives related to manufacturing processes. - Participate in project meetings and provide technical expertise during product introduction activities. Required Qualifications - Bachelor's Degree in Chemical Engineering, Process Engineering, Manufacturing Engineering, Biotechnology, or a related discipline. - 2-5 years of experience in manufacturing, process engineering, technology transfer, or process qualification environments. - Experience with MES systems, BOM management, and manufacturing documentation is preferred. - Knowledge of GMP, quality systems, and manufacturing validation processes is an advantage.