Production Engineer

Sanofi Group; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Sanofi Jurong Plant in Singapore seeks a Production Engineer to provide technical and operational support for API manufacturing, ensuring compliant, safe and efficient production activities. The role emphasizes process optimization, equipment performance and continuous improvement within a regulated environment.

Reporting to the Production Support Manager, you will collaborate with Manufacturing, Quality, Engineering, Supply Chain, HSE and Continuous Improvement teams to drive SMS-based

Qualifications

• Bachelor's degree in Chemical Engineering or related discipline.
• 3–5 years of pharmaceutical manufacturing experience.
• Experience in production operations, process optimization and troubleshooting.

Responsibilities

• Provide day-to-day technical and operational support for API manufacturing.
• Identify and implement process improvement initiatives to enhance efficiency and yield.
• Lead deviation investigations, RCA, and CAPA related to production processes.
• Support process validation, technology transfer and change control activities.
• Ensure compliance with cGMP, FDA and international regulatory requirements.

Education

Bachelors in Chemical Eng

Tools

Process instrumentation

Job description

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 RelationshipReporting 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, Technology Transfer & Equipment Reliability* Support **process 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 coordinate **preventive 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 applicable **HSE 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 of **safety, quality, compliance and continuous improvement** across manufacturing operations.. ## Knowledge & Experience Required### Education* **Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences or a related discipline – Required**### Experience* Minimum **3–5 years of relevant experience in pharmaceutical manufacturing**, preferably within an **API manufacturing environment**.* Practical experience supporting **production operations, manufacturing process optimization and technical troubleshooting**.* Proven track record in driving **continuous 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 of **API manufacturing operations, production processes and equipment**.* Good working knowledge of **cGMP, FDA and applicable international pharmaceutical regulatory requirements**.* Experience in **production process optimization, manufacturing troubleshooting and equipment performance monitoring**.* Familiarity with **deviation investigations, root cause analysis, CAPA and change control processes**.* Working knowledge of **process validation, qualification and technology transfer** principles.* Understanding of **preventive maintenance coordination and equipment reliability improvement**.* Familiarity with **Lean Manufacturing, SMS methodologies and continuous improvement practices**.* Exposure to **digitalization, automation and Industry 4.0 technologies** within manufacturing operations.* Good understanding of **HSE requirements, manufacturing risk assessments and safe operating practices**.* Strong analytical, problem-solving and technical troubleshooting capabilities.