Sanofi Group Associate Director Clean Utilities Operations in Framingham, Massachusetts
*Monday-Friday- 1st shift position-weekends as per business needs*
**Highly technical position
*Deviation, CAPA, and change control experience a huge plus*
*Clean Water System experience a must (WFI)*
**RODI- (Reserve Osmosis)
Regulatory Inspections and environmental monitoring*
The Framingham Facilities Operations (FFO) department is responsible for providing corrective and preventive maintenance and support services for the building(s), equipment and shared utilities at the Framingham site. FFO is directly responsible for reliable, efficient and sustained operation of the facility and all equipment. Additionally, through daily tasks, FFO supports current project operations and site goal objectives and ensures compliance with regulatory, corporate and site requirements.
Key Responsibilities & Position Summary
Monitor and direct the corrective, preventive, and operation/monitoring programs in a manner ensuring facility personnel safety, continual cGMP compliance, capital investment protection, and adherence to manufacturing and preventive maintenance schedules.
This position will also oversee shift supervisors to ensure timely completion of corrective and preventive maintenance and to minimize outages of production and utility systems.
Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills
Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance
Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action
Develop work plans, assign tasks, and supervise a large team or multiple small teams.
Manage staff resource requirements to support site strategic projects
Provide organizational and managerial structure that supports the various levels in the organization
BS degree in Engineering or Life Sciences with 8 years' of facilities management --OR-- AS degree in Engineering or Life Sciences with 12 years' of facilities management experience in the Bio or Pharma industry.
Minimum of 7 years of experience leading direct reports.
Working knowledge of qualified high purity water systems operations, testing and monitoring programs, industry standards and best practices.
Experience working within a regulated environment
Working knowledge of good asset management practices
Excellent communication skills
Solid understanding of Health, Safety, Environmental and Legal requirements for industrial plant operations.
In depth knowledge of Biotechnology manufacturing processes/concepts/techniques and engineering principles.
Experience managing electronic maintenance management and record keeping in a CMMS (Infor, Maximo)
Experience working with cross-functional teams, including Quality, ManufacturingTechnical Support, Facilities and Engineering and Validation.
Experience authoring and reviewing standard operating procedures, on-the-job-trainings and other controlled documents
Working knowledge of Deviation, CAPA and Change Management programs and systems (i.e. TrackWise, Phenix).
Experience leading internal and external regulatory audits describing clean utilities operations, environmental monitoring performance, results and corrective actions.
Experience with Lean Manufacturing System concepts and GEMBA culture
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.
- Sanofi Group Jobs