Primary:  The position is responsible for ensuring that the D&G QMT US facilities and equipment are maintained at operational readiness in a cGMP and ISO 13485 compliant state. This position oversees a comprehensive preventive maintenance and equipment lifecycle program, coordinates with third-party vendors and contractors and is a key partner to business leadership in the BU’s capital planning and site utilization strategy.  

Secondary: This position is responsible for leading, managing, and developing a team of facilities staff to fulfil the department’s mission. The department must be prepared to respond to emergency facility and/or equipment demands 24/7. The D&G QMT’s Environmental Health & Safety (EH&S) Program, which includes responsibility for the Hazardous and Biomedical Waste Management programs, is a key business partner.  

• Partner with Site Leads to ensure local resources are deployed effectively to support day-to-day production and on-going qualification of facility equipment.    

• Develop and implement best practices to improve efficiency, quality, and cost improvements with an emphasis of in-sourcing calibration and qualification activities.  

• Manage Facilities Budget and serve as key stakeholder in D&G QMT’s Capital Budget.  

• Maintain a thorough understanding of and adherence to cGMP and safety policies and procedures.  

• Write change-orders and create, review and revise Standard Operating Procedures (SOP’s).  

• Manage core services, including Utilities, Fire Safety, Property Insurance and Vendor Managed Services such as HVAC, Electrical, Plumbing, coordinating with Property Management as required.  

• Utilize the CMMS (e.g. Faciliworks) across available modules, including work order management, asset management, maintenance and calibration activities, etc.  

• Oversee the D&G QMT’s Water System, Cold Storage Equipment & Temperature Monitoring program.  

• Coordinate, alongside the Supply Chain, Quality and Science & Technology teams, to:  

1. support in the selection and installation of new assets, including analytical instrumentation and process equipment;  

1. perform maintenance on pumps, motors, agitators and other equipment;  

1. problem solve, including non-conformance, deviations and root cause investigations; and  

1. support continuous improvement programs.   

• Ensure that the D&G QMT’s Business Continuity & Disaster Recovery (BCDR) plans are up-to-date and consider the facilities-related components necessary to mitigate disruption to the business.  

• Provide on-call support for off-hours emergencies.