Microbiologist Executive

Role & responsibilities

• Perform microbiological analysis of purified water, potable water, compressed air, nitrogen, and other utility samples as per approved procedures.
• Conduct Environmental Monitoring (EM) of classified manufacturing areas, microbiology laboratories, warehouses, and utility areas using active air sampling, settle plates, contact plates, and surface swabs.
• Perform microbial limit testing and bioburden analysis of raw materials, intermediates, and APIs, wherever applicable.
• Prepare, sterilize, qualify, and maintain microbiological media, reagents, and laboratory solutions.
• Perform Growth Promotion Test (GPT), media qualification, and culture maintenance activities.
• Carry out microbial identification using approved microbiological techniques and maintain reference cultures.
• Perform trend analysis of environmental monitoring and utility monitoring data and report any adverse trends.
• Ensure routine calibration, qualification, verification, and preventive maintenance of microbiology laboratory instruments and equipment.
• Maintain laboratory notebooks, worksheets, logbooks, analytical records, and electronic data in compliance with ALCOA+ and data integrity principles.
• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), environmental monitoring excursions, laboratory deviations, and support implementation of Corrective and Preventive Actions (CAPA).
• Ensure compliance with cGMP, GLP, SOPs, EHS policies, and applicable pharmacopeial requirements (USP, EP, IP).
• Coordinate with QA, Production, Engineering, Validation, and Maintenance departments for microbiological investigations and contamination control activities.
• Participate in qualification and validation activities related to cleanrooms, utilities, equipment, and microbiological methods.
• Support internal audits, customer audits, and regulatory inspections by providing microbiology-related documentation and technical information.
• Maintain laboratory housekeeping, biosafety standards, and inventory of microbiological media, reagents, cultures, and consumables.
• Contribute to continuous improvement initiatives to strengthen microbiological controls and laboratory efficiency.