Position Summary:

The Manager, Manufacturing Maintenance is responsible for leading the Manufacturing Maintenance team to ensure the safe, efficient, and compliant operation, maintenance, and continuous improvement of pharmaceutical production equipment and GMP utilities. This role provides strategic leadership, technical direction, and operational oversight to drive reliability, minimize downtime, and optimize manufacturing support. The Manager partners closely with Manufacturing, Engineering, Quality Assurance, Technical Transfer, and Validation to achieve operational goals, regulatory compliance, and business objectives. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with cGMP, safety regulations, and company policies.

Job Responsibilities:

• Lead and manage the Operations Maintenance team to support manufacturing operations through proactive maintenance, troubleshooting, repair, and improvement initiatives.
• Assign daily tasks and develop weekly work schedules for maintenance personnel.
• Oversee preventive and predictive maintenance programs for all cGMP utilities and process equipment to maximize uptime and ensure compliance.
• Approve timekeeping, vacation requests, and performance evaluations for maintenance personnel.
• Champion training and development of maintenance technicians in equipment setup, operation, troubleshooting, and repair.
• Direct special projects, including equipment upgrades, system improvements, and cost-saving initiatives.
• Maintain and drive adherence to Good Documentation Practices (GDocP) and cGMP standards for all maintenance activities.
• Collaborate with Engineering, Validation, and Quality Assurance on equipment qualification, validations, and deviation investigations.
• Support regulatory inspections and customer audits related to equipment maintenance and reliability.
• Lead continuous improvement efforts, including root cause analyses (RCA) and corrective and preventive actions (CAPA) to eliminate equipment failures and improve operational efficiency.
• Develop, track, and report key performance indicators (KPIs) related to equipment reliability, maintenance performance, and resource utilization.
• Manage spare parts inventory strategy to ensure availability of critical spares while controlling costs.
• Ensure compliance with all applicable safety, environmental, and company policies and regulations.
• Perform other duties as assigned.

Required Skills:

• Strong leadership and team development skills, with the ability to motivate and manage technical teams.
• Proficient in maintenance management systems (such as BMRAM, SAP, or similar).
• Ability to read and interpret mechanical, electrical, pneumatic schematics, P&IDs, and technical manuals.
• Working knowledge of pharmaceutical manufacturing processes and cGMP regulatory requirements.
• Strong project management, troubleshooting, analytical, and problem-solving skills.
• Ability to prioritize work in a dynamic environment and manage multiple concurrent projects.
• Excellent written and verbal communication skills.
• Proficient with Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).

Education and Experience Requirements:

• Bachelor’s degree in Engineering, Maintenance Management, or related technical field, or equivalent experience.
• 5+ years of progressive experience in industrial maintenance (preferably in a cGMP pharmaceutical or aseptic manufacturing environment).
• 2+ years of supervisory or managerial experience leading maintenance teams.
• Experience with programmable logic controllers (PLCs), Distributed Control Systems (DCS), and automation systems preferred.
• Familiarity with pharmaceutical production equipment, including filling lines, washers, autoclaves, depyrogenation tunnels, lyophilizers, and environmental monitoring systems.
• Working knowledge of critical utilities (WFI systems, HVAC, compressors, steam systems, and vacuum systems).

• Experience with computerized Maintenance Management Systems like Blue Mountain or equivalent