Sterile Room Service Manager

About the position

The Sterile Room Service Manager, in collaboration with the Operations Manager, is responsible for ensuring the cleanliness, maintenance, and compliance of all classified areas within the facility. This role oversees cleaning, sanitation, maintenance, supply restocking, and material transfer while ensuring adherence to CGMP, FDA, and company SOPs. The manager drives efficiency, quality, and continuous improvement in cleanroom operations by implementing best practices and coordinating with cross-functional teams.

Responsibilities

• Organize, manage, and oversee the performance of the Sterile Cleaning Team.
• Supervise daily cleaning operations, ensuring regulatory and company compliance.
• Manage training programs for new and existing employees, ensuring proficiency in cleaning protocols and aseptic techniques.
• Address personnel issues, including attendance, performance evaluations, and training documentation.
• Conduct daily briefings with the cleaning team to align on priorities and address challenges.
• Periodically review batch records, SOPs, NCRs, and CAPAs to ensure accuracy and compliance.
• Ensure all cleanroom cleaning activities adhere to CGMP, FDA, and internal quality standards.
• Perform in-process quality checks and monitor sterility assurance measures.
• Support deviation investigations and implement corrective and preventive actions (CAPAs).
• Oversee scheduled maintenance and sanitation of all classified cleanroom areas.
• Ensure proper execution of cleaning logs, environmental monitoring documentation, and maintenance records.
• Coordinate with maintenance teams for preventive and corrective actions related to cleanroom equipment and air handling systems.
• Enforce 5S and Good Housekeeping practices to maintain a clean and organized working environment.
• Identify opportunities to improve cleaning procedures, efficiency, and compliance.
• Support new project development and implement enhanced cleaning protocols.
• Promote a culture of safety, ensuring adherence to PPE requirements and workplace safety guidelines.
• Participate in audits and inspections, implementing recommendations to enhance compliance and operational effectiveness.
• Perform all other duties as assigned or apparent.

Requirements

• Associate degree required; Bachelor’s degree preferred.
• Prior experience in a supervisory or managerial role in cleanroom or sterile manufacturing environments preferred.
• Strong understanding of aseptic cleaning techniques, CGMP, FDA, and regulatory compliance requirements.
• Knowledge of cleanroom classification, environmental monitoring, and sterilization techniques.
• Ability to review and interpret batch records, SOPs, and regulatory documentation.
• Experience managing training programs and conducting employee performance evaluations.
• Strong problem-solving skills with the ability to troubleshoot cleaning and compliance issues.

Nice-to-haves

• Certification in Lean Manufacturing, Six Sigma, or similar process improvement methodologies preferred.

Benefits

• Salary range: Based on experience.
• Hours of Work: 8-hour shifts or as needed based on production demand.