Manager, Cleanroom Operations

About the role

The Manager, Cleanroom Operations is responsible for overseeing the day-to-day operations, performance, compliance, and continuous improvement of cleanroom facilities and processes. The role ensures cleanroom operations meet required quality, safety, environmental, productivity, and regulatory standards while achieving production and operational targets.

Key responsibilities

• Lead and manage daily cleanroom operations to ensure smooth, efficient, and uninterrupted production activities.
• Ensure cleanroom facilities, processes, personnel, and equipment comply with established cleanroom standards and operating procedures.
• Monitor cleanroom environmental conditions, including temperature, humidity, pressure differentials, particle counts, and other critical parameters.
• Ensure proper gowning, hygiene, entry/exit, material handling, cleaning, and contamination-control practices are followed.
• Coordinate with Production, Engineering, Quality, EHS, Maintenance, and other functions to resolve operational issues.
• Ensure appropriate manpower planning, shift coverage, and resource allocation to support operational requirements.
• Ensure cleanroom operations comply with applicable company procedures, GMP requirements, ISO standards, and relevant regulatory requirements.
• Lead investigations into cleanroom deviations, environmental excursions, contamination events, and operational non-conformities.
• Establish and monitor operational KPIs, including productivity, efficiency, downtime, environmental compliance, quality performance, and cost.
• Lead, coach, and develop the cleanroom operations team to achieve operational and quality objectives.

About you

• Bachelor's Degree in Engineering, Manufacturing, Science, Operations Management, or a related discipline.
• More than 12 years of relevant experience in cleanroom operations, manufacturing, production, facilities, or a related environment.
• At least 3–5 years of managerial or supervisory experience managing cleanroom or controlled-environment operations.
• Experience in medical devices, pharmaceuticals, semiconductor, electronics, or other regulated manufacturing environments is preferred.
• Strong experience in contamination control, cleanroom standards, environmental monitoring, and operational compliance.
• Strong leadership and people-management skills.
• Good understanding of cleanroom operations and contamination-control principles.
• Knowledge of GMP, ISO standards, and relevant regulatory requirements.
• Strong problem-solving and analytical skills.
• Experience with Lean Manufacturing, 5S, Kaizen, or continuous improvement methodologies.