Manager, Equipment & Utilities Reliability

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Job Description

Essential Duties and Responsibilities

The Facilities, Maintenance & Calibration Manager is responsible for the operation, maintenance, compliance, and continuous improvement of GMP facilities, utilities, equipment, and building systems. This role oversees facilities, maintenance, and calibration personnel to ensure reliable support of manufacturing, laboratory, warehouse, and support operations while maintaining inspection readiness and regulatory compliance.

Facilities & Utilities
Manage facility operations including HVAC, compressed air, purified water, electrical, plumbing, fire protection, and building infrastructure.
Ensure facilities and utilities remain operational, compliant, and capable of supporting GMP activities.
Coordinate facility repairs, upgrades, and capital improvement projects.
Manage contractors, service providers, and facility vendors.

Maintenance & Calibration
Oversee preventive maintenance and calibration programs for facility, utility, manufacturing, and laboratory equipment.
Review and prioritize maintenance schedules, work orders, and calibration activities.
Monitor performance metrics and drive initiatives to improve equipment reliability and reduce downtime.
Ensure maintenance and calibration documentation is accurate, complete, and audit-ready.
Support investigations, corrective actions, and resolution of equipment-related issues.

Leadership & Collaboration
Lead, develop, and supervise facilities, maintenance, and calibration personnel.
Establish department goals, priorities, and performance expectations.
Promote a culture of safety, compliance, accountability, and continuous improvement.
Collaborate professionally with Quality, Manufacturing, Validation, Engineering, EHS, and other business functions to support operational objectives.
Communicate effectively with internal stakeholders, contractors, and vendors to ensure timely completion of projects, repairs, and maintenance activities.
Compliance & Technical Support
Ensure compliance with GMP, FDA, OSHA, and company requirements.
Support audits, inspections, change controls, deviations, CAPAs, and risk assessments.
Support equipment qualification, facility validation, equipment installations, commissioning, and startup activities.
Evaluate equipment failures and implement corrective and preventive actions.
Develop scopes of work, obtain quotations, and support facility-related projects.

Budget & Safety
Manage facility, maintenance, and calibration operating budgets.
Approve contractor services and monitor project expenditures.
Identify cost-saving opportunities while maintaining reliability and compliance.
Support EHS initiatives, emergency response activities, and contractor safety compliance.

Qualification and Experience

Education and Experience
Bachelor's degree in Engineering, Life Sciences, Facilities Management, or a related discipline preferred.
Minimum 7-10 years of experience managing maintenance, facilities, or engineering teams in a GMP-regulated environment.
Strong knowledge of facility utilities, maintenance systems, manufacturing equipment, and laboratory equipment.
Thorough understanding of GMP requirements associated with critical utilities, maintenance, calibration, and equipment operations.
Experience supporting audits, inspections, investigations, and quality systems.
Proficiency with Microsoft Office; experience with SAP, AutoCAD, or MS Project preferred.
Demonstrated leadership, organizational, project management, and problem-solving skills.
Excellent verbal and written communication skills with the ability to collaborate effectively across all levels of the organization.

Physical Requirements
Work is performed in both office and manufacturing environments. Position requires standing, walking, sitting, use of a computer, occasional lifting, climbing stairs/ladders, and use of required PPE, including safety shoes, eye protection, and respiratory protection when applicable. Ability to work safely around manufacturing, laboratory, and facility equipment is required.

Competencies