Principal Manufacturing Compliance Engineer

Job Title: Principal Manufacturing Compliance Engineer

Location: Framingham, MA

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.

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 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. Ready to get started?

Main Responsibilities 

• Practice and promotes 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 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:  Participate in timely completion of investigation, deviations and CAPA  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 analysisof data and information reported from a broad variety of sources. 

• Routinely assess progress made against Key Performance indicators to reach individual and team goals. 

• Sensitive to the broader work envir