Job Description Summary

The Manager, Maintenance Engineering & Reliability provides leadership for maintenance engineering, reliability programs, utility systems, technical compliance activities, and maintenance resources supporting manufacturing operations. Working closely with Manufacturing, Engineering, Quality, Safety, and Technical Operations teams, this position is responsible for ensuring the reliability, compliance, safety, and performance of facility, utility, and manufacturing support systems through effective leadership, resource management, continuous improvement, and operational excellence.

Job Description

Leadership Accountabilities:

Budget Responsibility

• Responsible for development, management, and performance of the Maintenance Engineering operating budget.
• Provides input and support for capital planning and capital project expenditures.

Span of Control

• Maintenance Trades, Systems Administrator(s), or other assigned personnel.
• Indirect Reports: Contractors, service providers, and cross-functional project teams.

Essential Duties and Responsibilities:

• Provides strategic leadership for maintenance engineering, reliability, utility systems, and technical support functions to achieve safety, quality, delivery, compliance, and cost objectives.
• Establishes organizational capability, staffing, and resource strategies to support current and future business requirements.
• Develops and implements maintenance systems, processes, and strategies that improve equipment reliability, maintenance effectiveness, and overall business performance.
• Ensures maintenance activities, facility systems, utilities, and equipment comply with cGMP, OSHA, corporate, and regulatory requirements.
• Provides strategic oversight of critical utility systems, including WFI, Clean Steam, Compressed Air, Nitrogen, HVAC, HEPA and supporting facility infrastructure.
• Provides oversight of Advanced Aseptic Manufacturing systems, including Vaporized Hydrogen Peroxide Decontamination Isolators, Depyrogenation Systems, Sterilization Systems, Aseptic Vial Filling and capping.
• Provides oversight of Automated Parenteral Inspection and Packaging systems, including Automated particulate and cosmetic inspection, Serialization, Cartoning and Case Packing.
• Establishes maintenance priorities, resource allocation plans, escalation processes, and response strategies to support safe, reliable, and compliant operations.
• Leads equipment and system investigations, identifies root causes, and drives corrective and preventive actions to improve reliability, compliance, and operational performance.
• Provides maintenance engineering leadership for capital projects, equipment installations, new product introductions, FATs, process improvements, and PMO initiatives.
• Collaborates with Manufacturing, Technical Operations, Engineering, Quality, Safety, and other cross-functional teams to improve process performance, equipment reliability, and operational effectiveness.
• Ensures inspection readiness and quality system effectiveness by overseeing procedures, investigations, change controls, maintenance practices, regulatory inspections, customer audits, and remediation activities.
• Leads employee development, succession planning, training effectiveness, performance management, and leadership development initiatives while fostering a culture of accountability, collaboration, Right First Time (RFT), and Continuous Improvement (CI).
• Develops and manages maintenance engineering budgets, forecasts resource requirements, and supports long-range planning activities.
• Communicates maintenance performance metrics, project status, operational risks, and improvement opportunities to support informed decision-making and achievement of business objectives.

Core Competencies:

Maintenance Engineering & Reliability Expertise:

• Demonstrates advanced knowledge of maintenance engineering, reliability programs, utility systems, facility infrastructure, equipment lifecycle management, maintenance strategies, and regulatory compliance requirements. Applies technical expertise to improve equipment performance, reliability, and operational effectiveness.

Leadership & Talent Development:

• Provides strong leadership through coaching, mentoring, performance management, workforce development, and succession planning. Builds engaged, capable teams that support current and future business needs.

Strategic Thinking & Business Acumen:

• Aligns maintenance engineering strategies with organizational goals. Effectively balances safety, quality, compliance, delivery, cost, and resource utilization to support business performance.

Compliance & Quality Focus:

• Maintains a strong commitment to cGMP, OSHA, regulatory, and corporate requirements. Ensures inspection readiness and supports robust quality system performance.

Communication & Influence:

• Communicate effectively with all organizational levels through presentations, reports, meetings, and technical discussions. Use data and expertise to influence decisions and drive results.

Cross-Functional Collaboration:

• Build strong partnerships with Manufacturing, Engineering, Quality, Safety, Technical Operations, and project teams to achieve common goals and improve organizational effectiveness.

Continuous Improvement & Operational Excellence:

• Driving a culture of continuous improvement through data analysis, root cause problem solving, reliability initiatives, process optimization, and implementation of best practices.

Education and Experience:

• Bachelor's degree in engineering, Engineering Technology, Facilities Management, Industrial Technology, Reliability Engineering, or a related technical discipline preferred.
• Master's degree preferred.
• Minimum 7-10 years of progressive experience in a regulated manufacturing environment.
• Minimum 5 years of leadership experience.
• Pharmaceutical manufacturing experience strongly preferred.
• Experience supporting utility systems, facility infrastructure, equipment reliability, maintenance strategy, and regulatory compliance programs preferred.

Physical Demands / Work Environment:

Work is performed in both office and manufacturing environments and requires regular use of computers and maintenance systems. Frequent walking throughout the facility is required to inspect equipment, support maintenance activities, oversee projects, and monitor utility operations. The position requires occasional climbing, bending, kneeling, reaching, and lifting to 35 pounds. Must be able to wear required PPE and work safely around manufacturing and utility equipment. Occasional support of off-shift activities, audits, outages, emergency response, and project implementations may be required.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.