Head of MA BioCampus Facilities and Engineering
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The MA BioCampus Facilities and Engineering (F&E) organization consists of the following functional groups: Engineering, Business Process & Project Controls, Commissioning and Qualification, Requalification, Validation, Engineering Documentation, Facilities, Housekeeping, Metrology and Maintenance Systems and Methods. It supports the Framingham and Northborough campuses which includes our commercial products, comprised of Fabrazyme, Thyrogen and Global Cell Banking operations as well as the 8 New York Avenue Biologics Facility. In addition, the F&E organization is responsible for our warehouses in Northborough and Framingham as well as programs/projects requiring approval, planning and execution across the Sanofi groups on the campuses.
This organization is responsible for providing Engineering and Maintenance support for all cGMP process and utility systems at Framingham Biologics, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity. This organization is also responsible for shared GMP and non GMP systems on the Framingham andNorthborough campuses as defined by Service Level Agreements. This role will support key campus stakeholders including but not limited to Research & Development, Science, Global Manufacturing Sciences and Technology and External Manufacturing. This organization is also responsible for non GMP maintenance of buildings on the campuses in conjunction with North America Sanofi Business services (SBS) and is the main group interfacing with SBS.
This position reports to the General Manager and Site Head of theMA BioCampus, with a dotted line to the Head of Engineering, Specialty Care Operations, with accountability to the MA BioCampusLeadership Team.
This position sits on theMA BioCampusSite Leadership Team (SLT) and will also serve as a member of which is responsible for defining and implementing the campus' operations strategy and ensuring the MA BioCampus remains in compliance with all safety, environmental, security and legal requirements.
Provide direct oversight in the fulfillment of the following specific responsibilities:
In cooperation with the Site F&E Leadership Team, develop the strategic vision for the department and execute that vision, by providing leadership and direction of its personnel, tracking regulatory changes, understanding department responsibilities, and then adjusting the operation accordingly.
Ensure efficient and effective operation by creating a proactive environment, developing & monitoring metrics, and communicating with End Users to add increased value to the business.
Participate as a key member of the SLT (Site Leadership Team) by cooperating cross functionally to achieve Manufacturing & Supply Priorities and Site Performance. Ensure that the people in Technical Services understand the shared accountability for Goals and Priorities with Operations. Participate as a key member for engineering and maintenance Functional Group and implement the engineering and maintenance Vision at the campus level.
Provide people and team development for increased company value and personal satisfaction. Work with department teams to ensure success and encourage collaboration and networking across all functions.
Ensure compliance with all regulatory requirements and good documentation practices are followed to track all work and make data analysis efficient.
Develop a strong Safety Culture that encourages taking the right amount of time to perform each task safely.
Collaborate and align with Global counterparts to ensure best Sanofi practices are embraced.
Drive cost savings, efficiency and effectiveness across the campuses.
Be a champion for the sites infrastructure and less visible technical enablers.
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 of our products and services.
Respecting the laws and operating within the applicable 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 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 motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.
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 as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence
BS or MS required in an Engineering or Life Science discipline
Minimum of 15 years of progressive experience in Biologics, Pharmaceutical or regulated industry
Experience working within a cGMP environment
Minimum of 8 years of management experience.
Experience managing large, complex facilities and engineering operations
Experience working with integrated commissioning and qualification practices.
Experience working within a regulated environment
Excellent communication skills
Experience managing large capital projects/investments
Solid understanding of Health, Safety, Environmental and Legal requirements for operations.
Biologics/Pharmaceutical facility startup experience
In depth knowledge of biotechnology processes/concepts/techniques and engineering principles.
Technical knowledge of biologics manufacturing systems and processes.
Excellent people leadership and change leadership skills.
Knowledge of statutory inspection requirements.
Experience with Sanofi Manufacturing System (SMS) standards and GEMBA culture
Special Working Conditions
Ability to gown and gain entry to manufacturing areas
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.