Senior Manager GMP Maintenance Operations

About the role

The Senior Manager, GMP Maintenance leads the 24/7 GMP Maintenance team that supports Devens Site Biologics Manufacturing Operations. This role is accountable for day-to-day management of the GMP Maintenance organization within the Devens Site Engineering Department and for ensuring that GMP manufacturing facilities, systems, and equipment are operated and maintained in a state of operational and inspection readiness.

Responsibilities

• Serve as a member of the Site Engineering Safety Committee.
• Model and champion safety, quality, and compliance across the Site Engineering organization.
• Set expectations and ensure adherence to EHS requirements, GMPs, governing building codes, and other applicable regulations; ensure the right support structure is in place to maintain compliance.
• Develop, implement, and monitor procedures and programs; identify gaps, define corrective actions, and drive sustained compliance.
• Define short- and long-term strategy aligned with Site Engineering and Devens Biologics objectives and communicate a clear team vision tied to site and business priorities.
• Build and develop the organization through hiring, coaching, talent development, and performance management while fostering an inclusive, supportive work environment.
• Establish systems and processes that reduce equipment variability and prevent defects that could impact manufacturing performance.
• Develop, implement, and track best-in-class maintenance and reliability KPIs; lead routine performance reviews and ensure actions address gaps and trends.
• Partner with Systems Lifecycle Engineering to define and execute reliability strategies that keep equipment operating to design specifications.
• Identify and deploy predictive analytics (including machine learning where appropriate) to improve equipment uptime and availability.
• Implement and sustain inspection-readiness programs to ensure facilities, systems, and equipment are maintained to the highest standards.
• Maintain a strong, collaborative relationship with the Integrated Facilities Management service provider to deliver best-in-class support services.
• Partner with site and corporate EHS to strengthen safety culture through effective processes, procedures, and risk-reduction strategies.
• Leverage modern data acquisition and analytics tools to improve asset performance while maintaining a highly compliant operation.
• Engage internal and external stakeholders—including Manufacturing, Quality, EHS, and local regulatory agencies—to meet site and business requirements.

Requirements

• Bachelor’s degree in Engineering, Facilities Management, or a related technical field (or equivalent experience).
• Minimum of 10 years of pharmaceutical/biotech industry experience, including expertise in metrology and/or maintenance systems, activities, and operations.
• Minimum of 10 years of experience leading an Engineering and/or Facilities team responsible for critical utilities supporting pharmaceutical or biotech manufacturing operations.
• Demonstrated experience managing operations and maintenance of critical utilities that support a large manufacturing campus.
• Strong experience with Quality Management Systems, including Change Control.
• Experience interacting with regulatory agencies and local government officials.
• Technical depth in a relevant discipline (e.g., metrology, maintenance, automation) and working knowledge of pharmaceutical manufacturing operations and building systems.
• Solid understanding of reliability engineering principles and maintenance best practices.
• Experience supporting upstream cell culture and downstream purification processes.
• Knowledge of clean utilities and GMP facility systems, such as WFI, clean steam, cleanroom HVAC, and Building Management Systems.
• Working knowledge of regulatory inspections; experience serving as an SME lead is preferred.
• Fundamental understanding of maintenance requirements for electrical systems, HVAC, and process heating/cooling utilities.
• Proven ability to lead a large, multi-skilled trades organization in a regulated manufacturing environment.
• Experience managing operating (OPEX) and/or capital (CAPEX) budgets greater than $10M.
• Ability to lead or contribute effectively to cross-functional project teams.
• Strong understanding of applicable regulations, including GMP, GLP, OSHA, and environmental requirements.
• Excellent leadership, communication, and presentation skills.

Qualifications

• Must be able to perform all essential job functions with or without reasonable accommodation.
• Must be legally authorized to work in the United States.
• Must be able to pass pre-employment drug screen and background check.
• Must be able to pass pre-employment physical examination.
• Must be able to pass pre-employment immunization screening.
• Must be able to pass pre-employment tuberculosis screening.
• Must be able to pass pre-employment hearing test.
• Must be able to pass pre-employment vision test.
• Must be able to pass pre-employment pulmonary function test.
• Must be able to pass pre-employment psychological evaluation.
• Must be able to pass pre-employment cognitive assessment.
• Must be able to pass pre-employment motor vehicle record check.
• Must be able to pass pre-employment credit report check.
• Must be able to pass pre-employment criminal background check.
• Must be able to pass pre-employment sex offender registry check.
• Must be able to pass pre-employment polygraph test.
• Must be able to pass pre-employment polygraph test.
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