Manager, Site Operations (cGMP Systems)

The Manager, Site Operations (cGMP Systems), is responsible for managing the maintenance of cGMP critical utilities for all buildings and clinical manufacturing equipment at the Gaithersburg Campus. This role will ensure the maximum reliability and uninterrupted supply of critical utility availability for all cGMP systems. These systems serve all areas of Research & Manufacturing.

The Manager will directly oversee all systems required for the site to maintain operations in emergency and normal operations. Leveraging industry knowledge and the collaborative relationships with end users, the manager will deploy in-house and contracted resources to operate and maintain systems in accordance with local regulations. Additionally, the manager will perform failure investigations and corrective/preventive actions, overseeing all system modifications, and improvements. This role will collaborate with the sustainability and project engineering teams to ensure efficient and effective utilization of the onsite equipment to minimize our carbon footprint while maintaining service expectations.

The Manager will evaluate new processes and technologies through consultation with external subject matter experts, to achieve cost effective and environmentally responsible. The Manager will interface with various departments to ensure processes and designs are compatible and support future process.

• Oversee the maintenance and project work performed by Technicians and On-Site Service Providers work including preventive, predictive and corrective maintenance services for cGMP critical utilities systems and clinical manufacturing equipment at the Gaithersburg Campus.

• Manage and support the acquisition, installation, operation, and enhancements of equipment and GMP critical utilities and clinical manufacturing equipment.

• Develop, improve and optimize PMs (Preventive Maintenance) to maximize equipment uptime and performance. Track uptime and performance through metrics and KPI’s

• Develop a technical staff to develop high-performing work teams within their functional areas and to maintain good working relationships within the department and site customers.

• Lead investigations caused by maintenance activities and support Site Operations Quality Systems team as required.

• Maintain the facilities operation that advances company core values and mission.

• Maintain daily awareness of technician headcount and assignments; maintain progress reports of maintenance activities and performance.

• Maintain facilities compliance with OSHA and company SHE policies & procedures. Management of facilities responsibilities to support ODS, MDE, WSSC compliance.

• Coordinate projects and maintenance with the Planning and Scheduling team to review Work Order (WO) scope of work, estimate costs and technician hours, plan work activities, order parts and supplies, prepare Maintenance Technician work schedule, obtain required permits (local building code, confined space, lock out tag out, hot work, and others), obtain access to building areas and notify affected occupants.

• Collaborate with Planning and Scheduling team Maintenance Planner to coordinate and triage all notifications ensuring proper information is recorded. Verify all related documentation is completed prior to releasing WO. Review completed WOs for accuracy and proper documentation.

• Collaborate with Materials Management team to determine stock levels, critical vs. non-critical spares, automatic ordering vs. ordering on demand.

• Collaborate with other Site Operations Managers to maintain and publish work priority system for 24/7 emergency response; and establish priority system for daily scheduled and unscheduled work activities. Ensuring coverage 24/7 to direct and coordinate emergency issues that may a