Associate Director Clean Utilities Operations
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**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**
Who You Are
You are an experienced manager with excellent organizational and communication skills who effectively works at all levels of the organization and cross functionally to deliver business objectives and supply quality product for our patients. You use your technical and regulatory skillset in a proactive way to direct your team to deliver highly reliable compliant clean utilities without risking the safety your team and fellow employees. You have a thorough understanding of good industry asset management practices and you demonstrate ownership and accountability for the long-term sustainable performance of the clean utility systems. You utilize a strong network of company and industry experts to identify and implement standardized best practices. In your role as system owner you use your industry and technical experience to lead productive conversations with internal and external auditors to produce strong audit results
The Framingham campus is a diverse Biotechnology hub conducting commercial manufacturing and strategic research and development operations. 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 Campus. FFO is directly responsible for reliable, efficient and sustained operation of the facility and all equipment. FFO supports current and future projects and site goal objectives and ensures compliance with regulatory, corporate and site requirements.
The Associate Director of Clean Utilities operations reports directly to the Senior Director of Framingham Facilities Operations and leads a team of skilled maintenance technicians. Primary objectives of the role are
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. Ensure the safe operation of Clean Utility systems and the safety of staff and fellow employees
Deliver on key performance indicators to ensure compliance with preventative and corrective maintenance schedules
Continually identify and pursue operational and staff efficiencies through good asset management and lean manufacturing concepts
Participate in and lead HSE and Quality investigations so that true root cause is determined and effective CAPA are established and implemented
Actively partner with Quality Contamination Control team to deliver exceptional Clean Utilities performance
Partner with Reliability Engineering and Capital Project portfolio management to create and execute a long term risk-based asset replacement strategy
Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and performance actions.
Maintain fiscal accountability for all assets, labor, and utilities. This includes forecasting, headcount, and spend tracking for all applicable facilities budgets.
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, Manufacturing
Technical 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.
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