Clean Room Supervisor

Overview

The Clean Room Supervisor is responsible for overseeing all operations within the clean room environment to ensure compliance with GMP (Good Manufacturing Practices), ISO standards, and company procedures. This role includes supervising production staff, ensuring adherence to cleanliness and safety protocols, and maintaining documentation for audits and inspections.

Responsibilities

• Supervise daily activities of clean room personnel to ensure efficient and compliant operations.
• Ensure that all clean room processes are performed in accordance with regulatory and company standards.
• Monitor and enforce proper gowning, hygiene, and clean room behavior.
• Train new employees and provide ongoing coaching and development to the team.
• Coordinate with Quality Assurance and Maintenance teams to resolve any process or equipment issues.
• Maintain accurate records of production, cleaning, and environmental monitoring activities.
• Prepare for and support internal and external audits and inspections.
• Identify areas for process improvement and implement corrective actions as needed.

Required Qualifications

• Proven experience in clean room operations, preferably in a medical device or pharmaceutical environment.
• Strong understanding of GMP, ISO 13485, and clean room protocols.
• Excellent leadership, communication, and organizational skills.
• Attention to detail and commitment to quality.
• Ability to work flexible hours, including shifts if required.
• High level in English.
• Data analysis ability.