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 Responsibilities1. Cleanroom Garment ManagementManage 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 ManagementOversee 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 & FoggingOversee 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 CompliancePrepare, review, and maintain SOPs related to:Garment managementWaste handlingEnvironmental controlsCleaning 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 CoordinationWork 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 QualificationMaster’s degree in Life Sciences, Biotechnology, Microbiology, Engineering, or related field.Diploma or certification in GMP, Cleanroom Technology, or Facility Management is an advantage.Experience3–6 years of experience in GMP cleanroom facility operations, preferably in:Cell therapyGene therapy / viral vector manufacturingBiopharmaceutical manufacturingHands-on experience with biosafety level (BSL-2/BSL-2+) facilities is preferred.Skills & CompetenciesStrong 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.

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