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Job title : Senior Process Engineer, APM

Location: Singapore

Hiring Manager: Process and Technology Manager, APM

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main responsibilities

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.

Contact with others

• Internal - Local & Corporate Staff

• External - Local Authorities and Equipment Vendors/Contractors

About You

• Degree in chemical engineering.

• Knowledge of process engineering, hands on experience on API technology, plant operations, continued process verification, PAT and process control/automated systems.

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)