Microbiologist
Core Responsibilities
· Sterilization Validation: Designing and executing studies to prove that sterilization methods (e.g., Ethylene Oxide, Gamma Radiation) consistently kill all microorganisms.
· Bioburden Testing: Quantifying the number of viable microorganisms present on a device before it undergoes sterilization (ISO 11737-1).
· Environmental Monitoring (EM): Testing air quality, surfaces, and water systems in cleanrooms to prevent contamination during manufacturing. Execute daily/weekly sampling of air (active and passive), surfaces (swabs/contact plates), and personnel within the cleanroom.
· Sterility Testing: Performing "Tests of Sterility" on finished products to verify they are free from viable organisms post-processing (ISO 11737-2).
· Bacterial Endotoxin Testing (BET): Using the LAL test to ensure devices don't carry fever-causing pyrogens, even if they are technically sterile.
- Batch Testing: Conduct routine bioburden testing and Bacterial Endotoxin Testing (BET/LAL) for all production batches.
- Water & Utility Testing: Perform microbial count and TOC (Total Organic Carbon) analysis on the plant’s water system.
- Sterilization Liaison: Coordinate with the EtO or Gamma sterilization facility, ensuring biological indicators (BIs) are placed and retrieved correctly.
- Inventory Management: Maintain the stock of media, reagents, and reference cultures needed for the lab without causing production delays.
- Contamination Control: Monitoring the "health" of the cleanroom environment (Grade B/C/D).
- Routine Batch Release: Testing every production lot for bioburden and endotoxins before it leaves the facility.
- Utility Monitoring: Ensuring the water (WFI/Purified) and compressed air used in manufacturing are not introducing microbes.
- Gown Qualification: Training and certifying production staff on how to dress and behave in a sterile environment.
Key Qualifications
- Education: Bachelor’s or Master’s in Microbiology, Biotechnology, or Life Sciences.
- Technical Knowledge: Proficiency in aseptic techniques, microbial identification, and Gram staining.
- Standards Proficiency: In-depth understanding of ISO 11135 (EtO sterilization), ISO 11137 (Radiation), and USP <71> (Sterility tests).
- Regulatory Compliance: Knowledge of FDA 21 CFR 820 and Indian Medical Device Rules (MDR).
Ideal Candidate Profile
- Experience: 4–7 years specifically in a Medical Device or Sterile Injectable plant.
Certification: Ideally an ISO 13485 Internal Auditor or trained in USP/EP cleanroom standards.
Pay: ₹40,000.00 - ₹60,000.00 per month
Benefits:
- Health insurance
- Life insurance
- Provident Fund
Work Location: In person
