Executive Microbiologist- Sterility

Job Summary:

We are seeking a dedicated and experienced Executive - Microbiologist (Sterility) to join our Quality Control Microbiology team in a sterile injectable manufacturing environment. The candidate will be responsible for performing and supervising sterility testing, monitoring aseptic practices, environmental monitoring, and ensuring microbiological compliance with cGMP and regulatory standards.

Key Responsibilities:

• Perform sterility testing of finished injectable products as per pharmacopoeial and regulatory guidelines (USP, EP, IP, JP).
• Operate and maintain sterility testing isolators or sterility testing rooms in compliance with aseptic techniques.
• Conduct environmental monitoring of aseptic manufacturing areas (settle plates, air sampling, surface monitoring, personnel monitoring).
• Carry out media fill (process simulation) testing and participate in its execution and analysis.
• Perform bioburden, endotoxin (LAL test), water testing, and microbial limit tests.
• Ensure proper documentation as per GDP (Good Documentation Practices).
• Maintain calibration and qualification records of instruments such as incubators, isolators, particle counters, etc.
• Investigate microbial deviations, sterility failures, and environmental excursions.
• Assist in the preparation of documents for regulatory inspections (USFDA, MHRA, EU, etc.) and participate in audits.
• Adhere to EHS (Environmental Health & Safety) guidelines and laboratory safety protocols.

Required Qualifications & Skills:

• Educational Qualification: M.Sc. in Microbiology / Biotechnology or B. Pharm with Microbiology specialization.
• Experience: 25 years of relevant experience in a sterile injectable pharmaceutical plant.
• Strong knowledge of cGMP, GLP, aseptic techniques, and sterile area practices.
• Hands-on experience with sterility testing isolators / sterility test rooms.
• Familiarity with regulatory guidelines (USFDA, EU GMP, WHO, PIC/S).
• Good communication and documentation skills.
• Ability to work in shifts (if required).

Preferred candidate profile