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.
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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.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
