Executive Microbiologist- Sterility

Job Summary:

Executive - Microbiologist (Sterility)

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