Manager

Facility & Operations Manager – GMP Clean room

The Facility & Operations manager is responsible for monitoring, managing, and ensuring compliant operation of GMP cleanroom facilities used for cell therapy and viral vector manufacturing . The role focuses on cleanroom garment management, biohazard waste handling, environmental condition monitoring, cleaning and disinfection (including fogging), and associated GMP documentation , ensuring continuous compliance with regulatory and biosafety requirements.

Key Responsibilities

1. Cleanroom Garment Management

• Manage issuance, collection, storage, and inventory of cleanroom garments (sterile and non-sterile) for classified areas.
• Ensure appropriate gowning practices are followed for different cleanroom grades (e.g., Grade A/B/C/D).
• Coordinate with approved vendors for garment laundering, sterilization, integrity checks, and qualification.
• Maintain garment usage logs, traceability records, and reconciliation.
• Support gowning qualification and periodic re-qualification activities of personnel.

2. Biohazard Waste Management

• Oversee segregation, labeling, collection, and disposal of biohazardous waste generated during cell therapy and viral vector manufacturing.
• Ensure compliance with biosafety, biomedical waste, and local regulatory requirements .
• Coordinate with authorized biohazard waste disposal agencies.
• Maintain waste logs, manifests, and disposal certificates.
• Support spill management, decontamination activities, and incident documentation.

3. Environmental Monitoring – Temperature & Relative Humidity (RH)

• Monitor and review cleanroom temperature and RH data to ensure operation within validated limits.
• Perform routine checks of environmental monitoring systems (BMS/EMS/data loggers).
• Ensure timely response to excursions, alarms, and deviations.
• Support investigation, root cause analysis, and corrective and preventive actions (CAPA) related to environmental excursions.
• Coordinate with maintenance for maintaining calibration and qualification status of monitoring instruments.

4. Cleanroom Cleaning, Disinfection & Fogging

• Oversee routine and periodic cleaning, disinfection, and fogging activities for cleanrooms and controlled areas.
• Ensure approved disinfectants, sporicidal agents, and fogging solutions are used as per validated cleaning procedures.
• Verify correct preparation, rotation, and contact time of cleaning agents.
• Coordinate fogging schedules and ensure pre- and post-fogging checks are performed.
• Review and approve cleaning and fogging records for completeness and compliance.

5. Documentation & GMP Compliance

• Prepare, review, and maintain SOPs related to:
• Garment management
• Waste handling
• Environmental controls
• Cleaning and fogging activities, etc.
• Ensure real-time, accurate, and compliant documentation as per GMP, GLP, and biosafety guidelines .
• Support change control, deviation management, CAPA, and risk assessments related to facility operations.
• Participate in internal audits, regulatory inspections, and facility walkthroughs.
• Support qualification and requalification of cleanrooms, utilities, and facility systems.

6. Cross-Functional Coordination

• Work closely with Manufacturing, Quality Assurance, Quality Control, EHS, and Engineering/maintenance teams.
• Support manufacturing operations by ensuring facility readiness and availability.
• Assist in training personnel on facility-related SOPs and cleanroom behavior.

Educational Qualification

• Master’s degree in Life Sciences, Biotechnology, Microbiology, Engineering, or related field .
• Diploma or certification in GMP, Cleanroom Technology, or Facility Management is an advantage.

Experience

• 3–6 years of experience in GMP cleanroom facility operations , preferably in:
• Cell therapy
• Gene therapy / viral vector manufacturing
• Biopharmaceutical manufacturing
• Hands-on experience with biosafety level (BSL-2/BSL-2+) facilities is preferred.

Skills & Competencies

• Strong understanding of GMP, cleanroom classifications, and biosafety requirements .
• Knowledge of environmental monitoring systems, cleaning validation, and disinfection strategies .
• Familiarity with regulatory expectations (CDSCO, FDA, EMA, WHO) for ATMP facilities.
• Good documentation practices and audit readiness mindset.
• Ability to handle deviations, investigations, and CAPAs.
• Strong coordination, communication, and organizational skills.