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 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.
*Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
About You
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:
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.
Leading People:
Sanofi's leaders are courageous motivators that inspire, build, and retain highly effective teams while managing for high performance and developing others.
Leading the Business:
Sanofi's leaders are effective at operating in an evolving, complex, and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers:
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.
Basic Qualifications:
Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 8 years in a cGXP manufacturing environment or a Master's degree in Sciences, Technical, Engineering or Advanced degree and 3 years of experience in cGXP manufacturing environment.
Experience in troubleshooting, investigation, and root cause analysis in a cGMP environment
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 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.
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 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.
Preferred Qualifications:
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, or Automation.
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
Special Working Conditions-
Ability to gown and gain entry to manufacturing areas.
Ability to work off shift hours, seldom, to support product release
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 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.
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.
