Production Operator

About the role

Join a global network that powers how Sanofi delivers—seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The primary responsibility of this role is the operation of general manufacturing equipment under close supervision in accordance with current relevant quality standards or standardized procedures and within safety guidelines in the production of Flublok Drug Substance in the large-scale recombinant protein production operations of the cGMP commercial manufacturing facility. This position requires good documentation skills and attention to detail.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Responsibilities

• Operate, maintain, clean, and sanitize large-scale cell culture bioreactors and associated operations such as media preparation, infection, and harvest.
• Execute large-scale bioreactor cell expansion using stainless-steel vessels and single-use bioreactors (SUBs), including transfer lines and ancillary equipment (tube welders, tube sealers, peristaltic pumps).
• Use water-for-injection (WFI) point-of-use taps and other related equipment.
• Clean and prepare workspaces and biosafety cabinets.
• Perform aseptic techniques, preventive maintenance, and changeovers for area equipment, including biosafety cabinets, magnetic mixers, and in-process testing equipment (cell analyzer, microscope).
• Identify, troubleshoot, and participate in resolving operational and equipment problems with minimal supervision, communicating effectively with management.
• Perform in-depth understanding and execution of routine techniques and processes.
• Handle all aspects of large-scale bioreactor cell expansion and protein production, including equipment preparation (CIP and SIP), appropriate use of raw materials (FIFO), material sampling for analytical testing, and filter integrity testing.
• Perform cell analysis and data interpretation using cell counters and microscopes for contamination checks.
• Operate and maintain ancillary equipment such as floor scales, turbidity meters, tube welders, tube sealers, and peristaltic pumps.
• Interact with other departmental personnel to assist in resolving manufacturing quality issues.
• Manage and analyze manufacturing data.
• Take initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
• Present and explain techniques and results of manufacturing processes to personnel outside the department.
• Ensure good documentation practices (GDP) in execution and reviews of production records.
• Complete all required cGMP training and any additional training assigned by management.
• Participate in the cleaning of the cGMP facility in accordance with sanitary maintenance SOPs.
• Follow established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.
• Work a flexible schedule, including weekends and holidays as required by the department.
• Work with Compliance regarding notification of deviations and CAPAs, providing information during investigations.
• Perform other duties as required.

Requirements

• High School degree with at least 3-5 years’ experience or training in a cGMP manufacturing environment OR BS degree with 1-3 years’ work experience.
• 1-3 years of bioreactor experience preferred.
• Working knowledge of manufacturing equipment and associated systems, including:
  • Valves (manual, automated, control)
  • Filters (cartridge, bag, membrane)
  • Piping systems (materials, fittings, layout, flow principles)
  • HMI (Human-Machine Interface) systems for equipment monitoring and control
  • Instrumentation for pressure, temperature, and flow monitoring
• Familiarity with safe startup, operation, shutdown, and maintenance procedures for process equipment.
• Experience working in a regulated manufacturing environment (e.g., food, pharmaceutical, chemical, or industrial) is a plus.
• Strong attention to detail and adherence to safety and quality standards.
• Knowledge of cGMP.
• Fluent in English, both written and spoken.
• Good communication and social skills.
• Proficiency in MS Word and Excel preferred but not required.
• Ability to lift up to 50 lbs. and bend/lift/move objects as part of the job.

Benefits

• Discover endless opportunities to grow your talent and drive your career, whether through promotion or lateral moves, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family with a wide range of health and wellbeing benefits, including:
  • High-quality healthcare
  • Prevention and wellness programs
  • At least 14 weeks’ gender-neutral parental leave