Engineer I

Sanofi; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Sanofi in Singapore is seeking an Engineer, Manufacturing to serve as the technical owner for Central Manufacturing Services (CMS), driving continuous improvement and operational reliability across CMS processes and equipment.

You will own technical integrity, lead change controls, collaborate with MSAT, Quality, and Automation to optimize media, autoclave, column packing, and automated logistics while ensuring GMP compliance and measurable performance gains.

Qualifications

• Strong knowledge of CMS processes incl. Media/Buffer prep, Autoclave ops, Column Packing, Automated Logistics.
• Proven record driving change and improvement projects with measurable outcomes.
• Proficient in data analysis and process trending for performance decisions.
• Working knowledge of GMP, change control, and data integrity.

Responsibilities

• Own technical integrity and performance of CMS processes and equipment; SME for CMS ops.
• Identify and lead continuous improvement across CMS; manage change controls.
• Drive equipment reliability, preventive maintenance, and validation activities.
• Lead deviation investigations and implement CAPAs to prevent recurrence.
• Ensure GMP, EHS, and site compliance; support audits and inspections.
• Collaborate with MSAT, Quality, Automation, and external vendors.

Skills

CMS processes

Change leadership

Data analysis

GMP knowledge

Deviations investigation

Lean Six Sigma

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Biotechnology or related

Tools

Single-use Systems

Job description

The Manufacturing team is expanding and seeking an Engineer, Manufacturing to serve as the technical process and system owner for Central Manufacturing Services (CMS), driving continuous improvement, change management, and operational reliability across CMS processes and equipment. The Engineer, Manufacturing will own the technical integrity and optimization of CMS processes - including Media and Buffer preparation, Autoclave operations, Column Packing, and Automated Logistics - ensuring these operate consistently within defined parameters, remain compliant with GMP requirements, and deliver measurable improvements in robustness, cost efficiency, and operational performance. The Engineer will work closely with MSAT, Quality, Automation, and other cross-functional teams to identify opportunities, drive change controls, resolve technical issues, and champion a culture of continuous improvement within CMS. This position reports to the Senior Manager, Manufacturing.

1. CMS Process & System Ownership Own the technical integrity and performance of assigned CMS processes and equipment systems. Maintain deep process knowledge and serve as the technical subject matter expert (SME) for CMS operations, supporting troubleshooting and technical decision-making. Monitor process performance data, trends, and key indicators; analyze patterns to identify opportunities for improvement or early warning signs of drift. Support process parameter definition, control limits, and acceptance criteria to ensure robust, repeatable operations.
2. Continuous Improvement & Change Leadership Proactively identify and drive continuous improvement initiatives across CMS processes, targeting measurable outcomes in cost reduction, cycle time savings, process robustness, and operational efficiency. Author, lead, and manage change controls to implement process improvements, equipment modifications, procedural enhancements, or system upgrades. Apply Lean, OE, and Six Sigma methodologies to eliminate waste, reduce variability, and optimize CMS workflows (e.g., Media & Buffer preparation cycle times, autoclave turnaround, logistics flow optimization). Track and report improvement project outcomes with clear metrics - cost savings, time savings, yield improvements, or deviation reduction. Collaborate with MSAT and Automation teams to leverage digital tools, process data analytics, and automation capabilities to enhance process control and efficiency.
3. Equipment & Process Reliability Drive initiatives to improve the consistency, reliability, and control of CMS equipment and processes, reducing variability and deviation risk. Lead or support equipment reliability and asset care improvements, including preventive maintenance optimization and equipment performance monitoring. Conduct and lead process risk assessments (e.g., FMEA) to proactively identify and mitigate operational risks within CMS. Support equipment qualification, validation, and periodic reviews to ensure continued fitness for purpose. Identify and recommend equipment or process upgrades to enhance reliability, reduce downtime, or improve efficiency.
4. Deviation & Investigation Support Lead technical investigation and root cause analysis of CMS-related process deviations, equipment failures, or performance issues. Develop and drive effective, sustainable corrective actions (CAPAs) to prevent recurrence and improve process robustness. Ensure deviations are closed in a timely manner with robust technical solutions. Track CAPA effectiveness and report outcomes to the Senior Manager, Manufacturing.
5. GMP, Safety & Compliance Ensure all CMS technical activities and documentation are performed in full compliance with GMP, EHS, and site requirements. Support audit and inspection readiness for CMS, ensuring technical documentation, process controls, and system validation are consistently inspection-ready. Maintain data integrity and traceability across CMS process documentation and change records.
6. Support to New Product Introduction (NPI) & Startup (As Required) Provide technical process expertise to NPI and process startup activities within CMS scope as assigned. Contribute to process risk assessments and readiness reviews for new CMS processes or equipment. Support process data collection, verification, and documentation during engineering runs or startup manufacturing.
7. Cross-Functional Collaboration Work closely with Manufacturing Operations to understand operational challenges and translate them into technical improvements. Collaborate with Quality, MSAT, and Automation teams to align on process improvements, data analytics, and system enhancements. Engage with Equipment vendors and engineering teams to support troubleshooting, optimization, and system upgrades.

Knowledge, Skills & Competencies

• Strong technical understanding of CMS processes, including Media and Buffer preparation, Autoclave operations, Column Packing, and Automated Logistics systems.
• Demonstrated ability to drive change and lead improvement projects with measurable outcomes (cost savings, time savings, deviation reduction).
• Proficient in data analysis and process trending to support performance monitoring and improvement decision-making.
• Working knowledge of GMP requirements, change control processes, and data integrity principles.
• Experienced in deviation investigation and root cause analysis methodologies (e.g., Fishbone, 5-Why, Fault Tree Analysis).
• Familiarity with Lean, OE, or Six Sigma tools and methodologies.
• Strong technical problem-solving and analytical thinking skills.
• Excellent technical writing and communication skills, with the ability to engage and influence cross-functional stakeholders.
• Strong team player with a proactive, continuous improvement mindset.

Qualifications / Requirements

• Diploma or Bachelor's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or a related discipline.
• 3-5 years of experience in biopharmaceutical manufacturing operations, process engineering, or technical support in a regulated GMP environment, with demonstrated experience in CMS or related support functions.
• Proven track record of leading or contributing to continuous improvement, change control, or process optimization initiatives with measurable outcomes.
• Experience with process data analysis, Single use Systems, deviation investigation, or equipment troubleshooting is advantageous.

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We are an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people's lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.