Production Engineer

The Production Engineer provides technical and operational support for the manufacture of Active Pharmaceutical Ingredients (APIs) at Sanofi's Jurong Plant, ensuring the safe, compliant and efficient execution of manufacturing operations. The role focuses on production process optimization, equipment performance, operational troubleshooting and continuous improvement , working closely with the Production team to ensure manufacturing activities meet established quality, safety, productivity and regulatory standards. The incumbent will also support process validation, technology transfer, deviation investigations, digitalization and manufacturing excellence initiatives , contributing to the continuous improvement of production efficiency, process reliability and operational performance. Reporting Relationship Reporting to the Production Support Manager , the Production Engineer will be a key member of the Production team and will work cross-functionally with Manufacturing, Quality, Engineering, Supply Chain, HSE and Continuous Improvement teams . Key Accountabilities Production Operations & Manufacturing Support • Provide day-to-day technical and operational support for API manufacturing operations , ensuring compliance with cGMP, quality and safety requirements. • Monitor manufacturing processes, production equipment and operational performance to ensure reliable and efficient execution of production activities. • Troubleshoot production-related technical issues, equipment abnormalities and process disruptions , working with relevant stakeholders to minimise operational downtime. • Support production scheduling and resource coordination to achieve manufacturing output targets while maintaining product quality and compliance. • Ensure accurate and timely completion of batch manufacturing records, production documentation and associated quality records . • Participate in production shift handovers to ensure effective communication of operational priorities, technical issues and outstanding actions. Process Optimization & Continuous Improvement • Identify, develop and implement process improvement initiatives to enhance manufacturing efficiency, productivity, process robustness and yield. • Apply Sanofi Manufacturing System (SMS) methodologies and structured problem-solving approaches to drive operational excellence. • Support initiatives aimed at reducing process variability, manufacturing waste, operational losses and equipment downtime. • Monitor production performance indicators and identify opportunities for improved operational efficiency and manufacturing reliability. • Collaborate with Manufacturing, Quality and Engineering teams to implement sustainable process improvements. • Support digitalization and Industry 4.0 initiatives , including the adoption of digital tools, automation and manufacturing performance monitoring technologies. Technical Investigations & Quality Compliance • Lead and/or support deviation investigations, root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) relating to production processes and equipment. • Participate in change control activities , including technical assessments and implementation of approved manufacturing changes. • Support quality risk assessments to identify, evaluate and mitigate risks affecting manufacturing processes and product quality. • Ensure manufacturing operations comply with applicable cGMP, FDA and international regulatory requirements , as well as established site procedures. • Participate in internal and external audits, regulatory inspections and associated inspection readiness activities. • Collaborate with Quality and other relevant functions to ensure timely resolution of manufacturing quality issues. Process Validation, Tec