Senior Process Engineer, APM

at  Sanofi US

Reporting to the Process and Technology Manager, the job holder will be a member of Process Centric Unit (PCU) when assigned in supporting the technical department and operations team on process technology and developing science driven solution.

Production monitoring/ Process improvement:

• Ensure that key attributes of the process (performance, CPP, CQA) to reduce variability are monitored and initiate/lead and implement process optimization ideas with the view towards improving efficiency, quality, robustness, yield and cost savings.
• Review continued process verification trends (CPP, CQA, & Yield), identify improvement levers and identify/ prioritize and plan process robustness initiatives including aligning with the Continuous Improvement (CI) Specialist , QA specialist and MSAT.
• Participate in CI meetings and yield meetings and lead in some Quick-Wins/ CI projects/ actions.
• Execute or support CI projects related to process robustness issues
• Lead for Process Validation, Process Performance Qualification and qualification of associated equipment by planning the activities and oversee the progress of the qualification.
• Lead/ Implement new product introduction and improvement strategies such as PAT technology and yields program.
• Lead the root cause analysis for process robustness deviations (Eg. DMAIC), propose and implement the CAPA in deviation reports. Actively link with other troubleshooting functions including PCU QA Specialist and PCU Asset Care Specialist in Technical department.
• Engage and work with people from multiple disciplinary functions for the change control, root cause analysis and other discussions.
• Perform technical and quality impact assessment for the new CI projects, plant modifications, process changes to ensure all modifications to plant, process and any risks have been reviewed and assessed appropriately from a process engineering viewpoint to ensure no unintended negative impact.
• Prepare and update batch record sheet, cleaning record sheet, SOP, qualification protocols and reports.
• Prepare and implement cleaning validation, process risk assessment using FMEA methodology.
• Prepare and conduct process training for operations team. Train and provide guidance to the junior engineers/chemists.
• Lead technology transfer project of new or existing chemical process to/from other sites when necessary.
• Participate in safety reviews/audits on plant, process and equipment. Ensure safe working in all areas of work by practicing and communicating safety.
• Participate in HAZOP and process safety analysis.
• Ensure compliance with HSE, Quality policies, cGMP requirements and defined procedures.
• Demonstrate Sanofi values and Play to Win behaviors and influence the people around you.