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 24/7large-scale therapeutic protein or vaccine manufacturing facility. Operations' mainfunctions are leading deviation investigations and managing CAPA implementation,partnering with direct manufacturing staff for enhancing and improving the manufacturing

• Practice and promotes safe work habits and adheres to Sanofi's safetyprocedures 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 PreventativeAction.
  
• Utilize manufacturing process knowledge and investigation skill sets to identifyand resolve manufacturing issues, improve process operations, and affect positive change.
  
• Represent Manufacturing Compliance Engineer team on cross-functional teamsinvolved in the design and implementation of new or updated quality systems inaccordance with the corporate standards, regulatory standards, cGMP, andindustry standards.
  
• Actively participate and provide input and feedback to cross functional teams toensure alignment on investigations and identified corrective and preventativeactions 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 whereopportunities 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 processchanges/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 indirectmanagement 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) areconsistently met
  
• Use experience and knowledge of manufacturing functional areas to proposecontinuous 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 reachindividual and team goals.
  
• Sensitive to the broader work environment and fosters relationships with partners, experts from other functions and customers in order to achieve tactical objectives.
  
• Monitor Quality Systems (e.g., investigations and CAPAs) activities to ensurecompliance with company and regulatory standards.
  
• Assist with Quality Management Review (QMR)/Quality Council.
  
• Support Corporate Compliance initiatives.
  

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  
• Being honest and treating people with respect and courtesy.
  
• Constantly striving to make Sanofi's a great place to work and a company
  
• respected for the quality of its people and products.
  
• Acting as role models for our fellow employees by acting responsibly, fairly and
  
• honestly in our dealings and exercising sound judgment in performing our jobs.
  

• Sanofi's leaders are courageous motivators that inspire, build, and retain highlyeffective teams while managing for high performance and developing others.
  

• Sanofi's leaders are effective at operating in an evolving, complex, and dynamicenvironment, providing clear direction and instruction to direct reports, andcontinuously looking internally and externally for best practices and areas forimprovement.
  

• Sanofi's leaders understand patient and customer needs and build relationships to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.
  

• Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 8 yearsin a cGXP manufacturing environment or a Master's degree in Sciences, Technical,Engineering or Advanced degree and 3 years of experience in cGXP manufacturingenvironment.
  
• Experience in troubleshooting, investigation, and root cause analysis in a cGMPenvironment
  
• Proficiency with critical thinking and technical writing
  
• Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices {part ofGxP}, validation principles, and applicable regulations
  
• Extensive experience with Quality Management Systems.
  
• Ability to learn and operate various enterprise systems including LIMS, SAP,OSI/PI, EMS, BMS, is required
  
• Regardless of format, able to carry all technical communications which will allowthe end-user, specifically QA personnel and regulatory inspectors, to arrive at the intended conclusions.
  
• Knowledge of GXP regulations and guidance.
  
• Ability to effectively coach and train employees.
  
• Demonstrate high-level of communication for cross-functionally and across levels, including timely identification of potential sources of conflict and resolveindependently or escalate to stakeholders promptly.
  
• Excellent verbal and written communication skills, with the ability to share vision,direction, and data with colleagues across all levels and in a wide range ofdifferent work groups
  
• Strong ability to balances the speed of delivering work with quality and showscommitment to make improvements in both aspects
  
• Demonstrate a high degree of engagement and involvement in all job-relatedactivities.
  
• Catalyst for selecting methods, techniques and evaluation criteria forobtaining results.
  
• Mentor junior members of team on technical topics. May
  
• potentially be a Qualified Trainer on investigation process.
  

• Bachelor's degree in Biology, Chemistry, Biochemistry, Chemical Engineering.
  
• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, orAutomation.
  
• Keeps tasks (deviations, CAPA, or CCR) on schedule, tracks them carefully, and delivers results on time; seeks assistance to solve a problem quickly to adhere to on-time delivery
  
• Experience with project management
  
• Experience in supervisory teams
  
• Ability to lead staff in absence to people manager
  

• Ability to gown and gain entry to manufacturing areas.
  
• Ability to work off shift hours, seldom, to support product release
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, 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 and at least 14 weeks' gender-neutral parental leave.