Production Engineer

TheProduction Engineer provides technical and operational support for the manufacture ofActive Pharmaceutical Ingredients (APIs) at Sanofi's Jurong Plant, ensuring the safe, compliant and efficient execution of manufacturing operations.

The role focuses onproduction 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 supportprocess 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 theProduction Support Manager, the Production Engineer will be a key member of the Production team and will work cross-functionally withManufacturing, Quality, Engineering, Supply Chain, HSE and Continuous Improvement teams.

Key Accountabilities

Production Operations & Manufacturing Support

• Provide day-to-day technical and operational support forAPI 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.
• Troubleshootproduction-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 ofbatch 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 implementprocess improvement initiatives to enhance manufacturing efficiency, productivity, process robustness and yield.
• ApplySanofi 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.
• Supportdigitalization and Industry 4.0 initiatives, including the adoption of digital tools, automation and manufacturing performance monitoring technologies.

Technical Investigations & Quality Compliance

• Lead and/or supportdeviation investigations, root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) relating to production processes and equipment.
• Participate inchange 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 applicablecGMP, 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, Technology Transfer & Equipment Reliability

• Supportprocess validation, process qualification and technology transfer activities associated with API manufacturing operations.
• Provide technical input into the implementation and qualification of new or modified manufacturing processes and equipment.
• Work closely with Engineering and Maintenance teams to coordinatepreventive maintenance, equipment troubleshooting and reliability improvement initiatives.
• Monitor equipment performance and support corrective actions to improve operational reliability and minimise unplanned downtime.
• Review and update relevant production procedures, technical documentation and manufacturing instructions to reflect approved process or equipment changes.

Safety, HSE & Operational Compliance

• Ensure production activities are conducted in accordance with applicableHSE policies, cGMP requirements and site safety procedures.
• Participate in operational risk assessments, safety reviews and investigations involving manufacturing processes and equipment.
• Identify potential safety and operational risks and work with relevant stakeholders to implement appropriate preventive and corrective measures.
• Promote a strong culture ofsafety, quality, compliance and continuous improvement across manufacturing operations.

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Knowledge & Experience Required

Education

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences or a related discipline – Required

Experience

• Minimum3–5 years of relevant experience in pharmaceutical manufacturing, preferably within anAPI manufacturing environment.
• Practical experience supportingproduction operations, manufacturing process optimization and technical troubleshooting.
• Proven track record in drivingcontinuous improvement and operational efficiency initiatives within a regulated manufacturing environment.
• Experience supporting manufacturing investigations, validation activities or technology transfers is advantageous.

Technical Knowledge & Skills

• Strong understanding ofAPI manufacturing operations, production processes and equipment.
• Good working knowledge ofcGMP, FDA and applicable international pharmaceutical regulatory requirements.
• Experience inproduction process optimization, manufacturing troubleshooting and equipment performance monitoring.
• Familiarity withdeviation investigations, root cause analysis, CAPA and change control processes.
• Working knowledge ofprocess validation, qualification and technology transfer principles.
• Understanding ofpreventive maintenance coordination and equipment reliability improvement.
• Familiarity withLean Manufacturing, SMS methodologies and continuous improvement practices.
• Exposure todigitalization, automation and Industry 4.0 technologies within manufacturing operations.
• Good understanding ofHSE requirements, manufacturing risk assessments and safe operating practices.
• Strong analytical, problem-solving and technical troubleshooting capabilities.

Pursueprogress, discoverextraordinary

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