Principal Manufacturing Compliance Engineer

Job Title: Principal Manufacturing Compliance Engineer

Location: Framingham, MA

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operations’ main functions are leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing, and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives.

Principal Manufacturing Compliance Engineer owns and ensures a robust investigations process, uses expert knowledge of compliance and GXP manufacturing processes to manage investigations, improvement initiatives, and major projects within manufacturing operations.

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.

Onsite position with hybrid potential three days a week.

• Practice and promote safe work habits and adheres to Sanofi’s safety procedures and guidelines.
• Lead and perform investigations, CAPAs and Change Controls (CCRs) for on‑time closure and supporting Annual Product Reviews.
• Provide guidance and direction to team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
• Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations, and affect positive change.
• Represent Manufacturing Compliance Engineer team on cross‑functional teams involved in the design and implementation of new or updated quality systems in accordance with the corporate standards, regulatory standards, cGMP, and industry standards.
• Actively participate and provide input and feedback to cross functional teams to ensure alignment on investigations and identified corrective and preventative actions.
• Escalate to management when investigations pose risk shipment or release and impact to department and site metrics.
• Maintain and report applicable department or organizational metrics.
• Routinely perform trend and statistical analysis as required to identify continuous improvement opportunities within manufacturing functional groups.
• Work to develop strategy and action plans for improving the system where opportunities are identified.
• Lead and actively participate in cross‑functional continuous improvement projects with Manufacturing, Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.
• Recognize and act on potential compliance issues and opportunities for process changes/improvement.
• Provide front room support during regulatory inspections.
• Represent investigation team during internal and external GxP audits.
• Partner with cross functional teams and team members, direct and indirect management chain to ensure the following: Ø Participate in timely completion of investigation, deviations and CAPA Ø Facilitation, Collaboration, completion, and active follow‑up.
• Support investigation team to ensure site Key Performance Indicators (KPIs) are consistently met.
• Use experience and knowledge of manufacturing functional areas to propose continuous improvements to deliver efficiency gains.
• Assess customer needs and provides effective solutions through regular analysis of data and information reported from a broad variety of sources.
• Routinely assess progress made against Key Performance indicators to reach…