Position Overview

We are seeking a hands-on Process Maintenance Supervisor to lead our maintenance team at a GMP manufacturing facility in Holly Springs, NC. This role is responsible for supervising day-to-day maintenance activities for process equipment, ensuring high equipment reliability, compliance with GMP and safety standards, and effective development of the maintenance team.

You will oversee a team of process maintenance technicians, manage individual performance and development, and coordinate maintenance tasks that support a 24/7 manufacturing operation.

Key Responsibilities

Team Leadership & People Management

• Supervise a team of process maintenance technicians, including daily direction and workload assignment.
• Conduct regular 1:1 check-ins and performance reviews, providing coaching, feedback, and development planning.
• Approve and track time cards, manage schedules, PTO, and attendance in alignment with company policies.
• Oversee and track training requirements for direct reports to ensure compliance with GMP and site training matrices.
• Foster a culture of safety, ownership, collaboration, and continuous improvement within the maintenance team.

Maintenance Planning & Execution

• Plan, prioritize, and oversee day-to-day preventive and corrective maintenance on process equipment, including (but not limited to):
  • Bioreactors
  • Centrifuges
  • Ultrafiltration skids
  • Parts washers
  • Autoclaves
  • Isolators
  • Fillers
• Ensure maintenance activities are executed efficiently and documented accurately to minimize equipment downtime and support production schedules.
• Provide recommendations to develop and optimize preventative maintenance plans and frequencies.
• Assign and monitor work orders, ensuring timely completion and proper documentation in the CMMS.
• Support installation, commissioning, and qualification of new process equipment as needed.

Technical & GMP Responsibilities

• Guide technicians in diagnosing and troubleshooting mechanical, electrical, and control system issues on process equipment.
• Contribute to the development, review, and revision of SOPs and work instructions for process maintenance activities.
• Ensure all maintenance work is performed in compliance with cGMP, internal quality standards, and regulatory expectations.
• Maintain and review accurate maintenance records, logs, and documentation to ensure data integrity and audit readiness.
• Coordinate and participate in spare parts assessments, inventory use, and recommendations for critical spares.

Safety & Compliance

• Lead by example in adhering to all safety requirements and safe work practices.
• Ensure technicians complete all required EHS and GMP training and follow established procedures.
• Identify and promptly report unsafe conditions or hazards to management and/or Environmental, Health & Safety (EHS).
• Support site operations and emergency work orders during off-hours, as needed.

Continuous Improvement

• Apply lean manufacturing and reliability principles to reduce downtime, improve equipment performance, and streamline maintenance processes.
• Identify and implement improvements in maintenance procedures, tools, and systems.
• Collaborate cross-functionally with Manufacturing, Engineering, Quality, and EHS to support site goals.

Qualifications

Required:

• Strong knowledge of mechanical, electrical, and control systems relevant to biopharmaceutical process equipment.
• Demonstrated knowledge of GMP requirements and working in a regulated environment.
• Effective written and verbal communication skills.
• Proven team leadership or lead/mentor experience in a maintenance or technical role.
• Strong problem-solving, organizational, and time management skills.
• Ability to train and mentor technicians and drive accountability.
• Detail-oriented with a focus on accuracy and compliance.
• Familiarity with lean manufacturing principles and continuous improvement.

Preferred:

• Prior experience in a GMP biopharmaceutical, pharmaceutical, or medical device manufacturing environment.
• Experience using a Computerized Maintenance Management System (CMMS).
• Experience supervising or coordinating a maintenance team in a 24/7 or high-throughput manufacturing setting.
• Technical degree or trade school certification in a relevant field (Mechanical, Electrical, Industrial Maintenance, etc.).

Work Environment

• On-site role in a GMP manufacturing facility.
• May require off-shift or weekend work to support production and emergency maintenance activities.
• Role involves working in cleanroom and manufacturing areas with appropriate gowning and PPE.