Manager, Facilities

Manager, Facilities

Responsible for the maintenance of facilities-related systems and equipment, campus upkeep, and soft services to ensure efficient operation of facilities and building systems within a medical device campus environment. Responsibilities include maintaining compliance with EHS standards, Standard Operating Procedures, and cGMP. Supervise, guide, and mentor Facilities staff, prioritizing Safety, Quality, and Delivery, focusing on Patients First. Assign daily tasks to technicians to address internal customer requests. Oversee performance management and employee evaluations. Lead improvement projects, ensuring compliance with site procedures, local laws, and Quality and EHS regulations. Support the Facility Master Plan by continuously reviewing the capacity and reliability of equipment and building systems. Develop and enhance preventive maintenance programs to ensure the reliability of all systems, equipment, Clean Rooms, and building integrity. Apply best practices and metrics to improve performance. Maintain records to demonstrate compliance with safety and environmental laws, regulations, or policies. Prepare reports on operations and system productivity or efficiency. Oversee Janitorial Services, GMP Cleaning, Caf Services, and Maintenance contractor management, ensuring uninterrupted operations. Lead cross-functional teams to resolve system or quality-related issues, conducting thorough root cause analysis using engineering knowledge and Business Excellence tools. Conduct proactive Gemba walks to evaluate and implement improvements. Review and control the assigned budget, participate in annual budgeting, and plan projects to ensure spending meets objectives. Manage the Space Planning process, ensuring accuracy and anticipating space needs. Position requires 5% domestic and 5% international travel; expenses paid by employer.

Minimum Requirements : Bachelor's or equivalent degree in Electrical Engineering, Mechanical Engineering or a related field, and 4 years of experience in the job offered or in facilities engineering, utilities engineering or a combination of these fields (must include exp. with electrical & mechanical systems in a regulated industry.) Experience can be acquired pre or post bachelor degree. Work experience to include :

• Two years of experience in facilities engineering, including estimating assets reliability and maintenance needs, preparing for plant maintenance shutdowns and turnarounds, and contributing to the development of Facility Master Plan strategy, Strategic Financial Plans, and budget management.
• Working in a cross-functional team environment, including inter-departmental teams, to integrate all business strategic plans and use them to develop a holistic Facility Master Plan strategy and serve as the critical contact representing the organization on contracts or projects.
• Managing assigned team and providing coaching and feedback, including responsibility for all employee actions including hire and fire authority and partnering with HR on all aspects of employee relations.
• Managing contractors (General Contractors, Mechanical Contractors, Electrical Contractors, and utilities equipment installation technicians) to meet quality and timeliness expectations for facility management of a medical device production organization.
• Working with the following laboratory equipment for medical device manufacturing : HEPA filtration systems and Validated Monitoring System for Differential Pressures, Temperature, and Relative Humidity.
• Working with the following facilities equipment for medical device manufacturing : Heating, Ventilation & Air Conditioning (HVAC), Plumbing, Oil Free Air Compressors, Electrical Substation, Reverse Osmosis De-Ionized (RODI) Water Systems, Emergency Power Generation System, and Building Management System (BMS).
• Manufacturing facilities project management, including : project scope determination and control, project timeline creation and control, project risk management, project scheduling, developing project or program plans, managing customer expectations, mitigating risks, and delivering projects on time and within budget.
• Ensuring compliance with Environmental Health and Safety and Quality guidelines as they relate to the medical device manufacturing Facilities maintenance.
• Using MS Office Suite (Excel, Teams, MS Word, and PowerPoint) to create and maintain records on compliance with safety and environmental laws, regulations, and policies, and to prepare reports on operations and system productivity and efficiency.
• Working with FDA regulations for medical device industry to ensure projects are planned and delivered in compliance with regulatory requirements.
• Analyzing and resolving manufacturing and compliance issues (CAPA, NCRs, and audit observations) related to medical device manufacturing facilities (infrastructure).
• Supporting Capital Projects planning and execution following Compliance and EHS procedures and regulatory requirements for the medical device industry; must include supporting qualification activities (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to meet FDA and DEKRA regulations.
• Planning construction projects, managing engineering design, overseeing construction qualification and commissioning, and supporting qualification and validation activities; must include developing Project Turn Over Packages documentation, including drawings updates.
• Establishing and leading facilities equipment and system Reliability Centered Maintenance program using CMMS (Computerized Maintenance Management System).
• Supervising Total Equipment Life Cycle Management and planning lifecycle replacement of equipment for Utilities, Clean Rooms, and Facilities Systems; must include managing Equipment and Services Requisitions (RFP / RFQ).
• Overseeing manufacturing support tasks for medical devices production; must include instructing technicians on conducting tests, as well as training technicians and coordinating their work.