Associate Director, GMP Maintenance

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The Associate Director GMP Maintenance provides leadership and direction to the 24/7 GMP Maintenance team supporting the Devens Site Biologics Manufacturing Operations. The primary responsibility of this role is the management of the GMP Maintenance team within the Devens Site Engineering Department. This GMP Maintenance team is responsible for ensuring that all Devens GMP manufacturing facilities, systems, and equipment are operated and maintained to ensure operational and inspection readiness. The Associate Director GMP Maintenance is responsible for developing, implementing, and maintaining a strategic plan to ensure the maximum efficiency and availability of manufacturing equipment, associated critical utilities, and related facilities at optimal cost and within the required expectations of quality, safety, and protection of the environment.

Key Responsibilities:

• Member of the Site Engineering Safety Committee.

• Champions safety and compliance as a leader within the Site Engineering Department.

• Set expectations and ensure adherence to Safety and Environmental regulations, Good Manufacturing Practices, Governing Building Codes, and other applicable industry regulations related to the manufacture of pharmaceutical products. Ensure that the right support structure is in place to facilitate compliance with those requirements.

• Supports the development of related procedures and programs, implement and monitor performance. Identifies areas of opportunity and prepares specific action plans to increase awareness and to maintain compliance.

• Set short- and long-term strategies for the team that aligns with Site Engineering and Devens Biologics objectives. Communicate a clear vision for the team aligned with the Devens Site and overall business objectives.

• Develop and manage the teams through hiring, talent development, coaching, and performance management in a manner that creates an inclusive and supportive work environment.

• Develop and implement systems and processes that minimize inconsistencies or defects in equipment that could lead to variability in equipment/system output.

• Develop, implement, and track best in class maintenance and reliability KPI’s and ensure the appropriate review process is in place so actions are being taken to address performance issues.

• In collaboration with the Systems Lifecycle Engineering organization, define and implement strategies to ensure that equipment is operating reliably and per design specifications.

• Identify opportunities to implement and utilize predictive analytics (including machine learning where applicable) to improve equipment uptime and availability.

• Implement and maintain inspection readiness programs to ensure that the manufacturing equipment, systems, and facilities are always inspection-ready and maintained to the highest standards.

• Maintain a collaborative and positive working relationship with our Integrated Facilities Management service provider to deliver best in class facilities support services.

• Champion Safety by partnering with site and corporate EHS to develop and implement processes, procedures, and strategies to ensure that we are creating an environment and culture to keep our employees safe.

• Utilize state-of-the-art data acquisition and analytical technology to drive asset performance while maintaining highly compliant facilities.

• Broad knowledge of Good Manufacturing Practices, Building Codes, OSHA regulations, and Industry Regulations related to the manufacture of pharmaceutical products.

• Develops relationships with diverse groups across the client base at the Devens site. Work within a team environment with other Site Engineering functions, including E