Expert Microbiologist

Job Title: Microbiologist

About the Job:

We are seeking a highly motivated and experienced professional in microbiology, biotechnology or a related field to join our team. The ideal candidate will have a strong background in microbiology with 2-4 years of experience in the API/Pharmaceutical industry.

Main Responsibilities:

• Perform environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions.
• Sampling and testing of purified water and raw water.
• Microbial Limit tests, BET, Sterility testing etc of water, APIs and KSMs.
• Support for cleaning validation by performing swab/rinse microbiological analysis.
• Conduct microbiological validation studies (e.g., filter integrity testing, media fills for aseptic processes).
• Participate in qualification of controlled areas, equipment, and utilities (HVAC, water systems, compressed air).
• Prepare and review Standard Operating Procedures (SOPs), protocols, and reports.
• Maintain accurate microbiological records as per GMP and data integrity requirements (ALCOA+ principles).
• Support regulatory inspections and customer audits and respond to microbiology-related queries.
• Participate in out-of-specification (OOS) or out-of-trend (OOT) investigations related to microbial results.
• Perform root cause analysis and propose corrective and preventive actions (CAPA).
• Conduct microbiological risk assessments of processes and systems.
• Maintain microbial culture collection and reference strains.
• Ensure calibration and qualification of lab instruments (incubators, autoclaves, laminar airflows, microscopes).
• Proper handling, disposal, and biosafety practices for microbial cultures.
• Train production and quality staff on microbiological hygiene and aseptic practices.
• Continuous improvement of contamination control strategies.