Production Engineer - API Manufacturing

About the role

The Production Engineer provides technical and operational support for the manufacture of Active Pharmaceutical Ingredients (APIs) at Sanofi's Jurong Plant, ensuring manufacturing is safe, compliant and efficient. Reporting to the Production Support Manager, the role works closely with the Production team and cross-functionally with Manufacturing, Quality, Engineering, Supply Chain, HSE and Continuous Improvement teams.

Key responsibilities

• Support day-to-day API manufacturing, monitor processes and equipment, troubleshoot issues and help achieve production targets while maintaining quality and compliance.
• Complete batch manufacturing records and production documentation accurately and on time, and take part in shift handovers.
• Drive process improvement using Sanofi Manufacturing System (SMS) methods, reduce variability, waste and downtime, and support digitalization and Industry 4.0 initiatives.
• Lead or support deviation investigations, root cause analysis (RCA) and CAPA, and take part in change control, quality risk assessments and audits.
• Support process validation, qualification and technology transfer, and coordinate preventive maintenance with Engineering and Maintenance.
• Ensure operations comply with cGMP, FDA and international regulatory requirements, and follow HSE policies and safety procedures.

Required profile

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences or a related discipline.
• Minimum 3-5 years of experience in pharmaceutical manufacturing, preferably in an API environment.
• Proven track record in continuous improvement in a regulated manufacturing setting; investigation, validation or technology transfer experience is advantageous.

Required skills

• Good working knowledge of cGMP, FDA and international regulatory requirements.
• Familiarity with deviation investigations, RCA, CAPA, change control, process validation and technology transfer.
• Lean Manufacturing, SMS methodologies and continuous improvement practices.
• Exposure to digitalization, automation and Industry 4.0 technologies.
• Strong analytical, problem-solving and technical troubleshooting abilities.