Manager, Healthcare

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 clean rooms 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 clean rooms, 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.