Principal Manufacturing Compliance Engineer

Job Title: Principal Manufacturing Compliance Engineer

• Location: Framingham, MA
  
  
  

About The Job

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply,youllhelp 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 manufacturings 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.

Onsite position with hybrid potential three days a week.

About Sanofi

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.

Main Responsibilities

• Practice and promotes safe work habits and adheres to Sanofis 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: 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 analysis of 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 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 ensure compliance with company and regulatory standards.
• Assist with Quality Management Review (QMR)/Quality Council.
• Support Corporate Compliance initiatives.
  
  
  

About You

Basic Qualifications

• Bachelor's degree with 8 years in a cGXP manufacturing environment.
• OR Advanced degree with 3 years of experience in cGXP manufacturing environment.
• Experience in troubleshooting, investigation, and root cause analysis in a cGMP environment
• Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices {part of GxP}, 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 allow the end-user, specifically QA personnel and regulatory inspectors, to arrive at the intended conclusions.
• 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 resolve independently 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 of different work groups
• Strong ability to balances the speed of delivering work with quality and shows commitment to make improvements in both aspects
• Demonstrate a high degree of engagement and involvement in all job-related activities. Catalyst for selecting methods, techniques and evaluation criteria for obtaining results. Mentor junior members of team on technical topics. May potentially be a Qualified Trainer on investigation process
  
  
  

Why choose us?

• 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 its 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 andwellness programs and at least 14 weeks gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
  
  
  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.