Microbiologist

Role: Microbiologist

Department: Quality Control / Microbiology
Reports To: Microbiology Section Head / QC Manager
Location: Vapi, Gujarat
Employment Type: Full-Time

Company Overview

A leading pharmaceutical manufacturing company committed to producing safe, effective, and high-quality drug products in compliance with cGMP and regulatory standards. We are seeking a detail-oriented Microbiologist to join our Quality Control team.

Job Summary

The Microbiologist will be responsible for performing microbiological testing of raw materials, in-process samples, finished products, water systems, and environmental monitoring to ensure compliance with cGMP, pharmacopoeial standards (USP/BP/EP/IP), and regulatory requirements. The role involves executing tests accurately, documenting results, and supporting investigations related to microbial contamination.

Key Responsibilities

• Perform microbiological testing including Bioburden, Sterility Testing, Bacterial Endotoxin Test (BET/LAL), Microbial Limit Test (MLT), and Growth Promotion Test.
• Conduct Environmental Monitoring (EM) of cleanrooms, including viable and non-viable particle counts, surface monitoring, air sampling, and personnel monitoring.
• Test water systems (Purified Water, Water for Injection) as per schedule.
• Perform identification of isolated microorganisms using conventional and/or automated identification systems.
• Maintain and calibrate microbiology lab equipment (autoclaves, incubators, laminar air flow units, biosafety cabinets).
• Prepare, sterilize, and control culture media, reagents, and biological indicators.
• Document all testing activities in compliance with GDP (Good Documentation Practices) and maintain accurate laboratory records/logbooks.
• Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) microbiological results, and support root cause analysis and CAPA.
• Ensure adherence to cGMP, GLP, and safety protocols within the microbiology laboratory.
• Participate in method validation, method transfer, and microbial method suitability studies.
• Support internal and external audits (FDA, WHO-GMP, EU-GMP, customer audits) by providing documentation and technical justification.
• Maintain aseptic technique and ensure sterility of testing environment.
• Perform disinfectant efficacy studies and qualification of cleanroom areas.
• Ensure timely calibration/validation of microbiology equipment and maintain equipment logs.
• Train new team members on microbiological techniques and SOPs, as required.

Required Qualifications

• Education: M.Sc./B.Sc. in Microbiology, Biotechnology, or related life sciences discipline.
• Experience: 1–2 years of relevant experience in a pharmaceutical/biotech QC microbiology laboratory (freshers may be considered for junior roles).
• Strong understanding of cGMP, GLP, and pharmacopoeial (USP/EP/BP/IP) guidelines.
• Hands-on experience with sterility testing, BET, bioburden, and environmental monitoring.
• Familiarity with regulatory requirements (US FDA, WHO, EU-GMP, MHRA).

Preferred Skills

• Experience with automated microbial identification systems (e.g., VITEK, BD Phoenix).
• Knowledge of rapid microbiological methods (RMM).
• Exposure to LIMS (Laboratory Information Management System).
• Strong documentation, analytical, and problem-solving skills.
• Good communication skills and ability to work in a team-oriented environment.

Key Competencies

• Attention to detail and accuracy
• Strong aseptic technique
• Analytical and investigative mindset
• Time management and ability to handle multiple tests/deadlines
• Compliance-oriented mindset

Work Environment

• Laboratory-based role requiring gowning and adherence to cleanroom protocols.
• May require working in shifts, including weekends, based on production and testing schedules.

Pay: ₹12,000.00 - ₹15,000.00 per month

Benefits:

• Commuter assistance
• Flexible schedule

Work Location: In person