Contamination Control Specialist

Sanofi; Framingham (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

Sanofi Framingham Biologics Campus is seeking a Contamination Control Specialist to join the Sterility Assurance and Microbiology team. You will apply microbiological control principles to maintain environmental control and support manufacturing quality on the shop floor.

The role focuses on leading risk assessments, investigations of contamination events, and CAPA development in collaboration with cross-functional teams to ensure product quality and compliance.

Responsibilities

• Leading as SME specific subjects part of the Contamination Control SOP in her/his area of expertise
• Conducting risk assessments related to contamination control
• Overseeing sites activities and performance for contamination control systems in her/his scope of responsibilities
• Leading investigation following contamination control failures and proposing corrective and preventive actions (CAPA)
• Collaborating with cross-functional teams to ensure product quality
• Ensuring presence on the shop floor to oversee practices, identify

Job description

Job Title: Contamination Control Specialist
Location: Framingham, MA

About The Job:

The Sterility Assurance and Microbiology (Contamination Control) Department supports quality and manufacturing activities at Sanofi Framingham Biologics Campus by identifying possible trends from microbial contaminants that may interfere with the quality of the product during different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the areas are operating in a state of environmental control.

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.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Leading as SME specific subjects part of the Contamination Control SOP in her/his area of expertise
• Conducting risk assessments related to contamination control
• Overseeing sites activities and performance for contamination control systems in her/his scope of responsibilities
• Leading investigation following contamination control failures and proposing corrective and preventive actions (CAPA)
• Collaborating with cross-functional teams to ensure product quality
• Ensuring presence on the shop floor to oversee practices, identify