Pathogenic Specialist

Job Title: Microbiologist

About the Role:

We are seeking a highly skilled Microbiologist to fill this challenging position.

Responsibilities:

• Perform environmental monitoring of classified areas to ensure aseptic conditions by sampling and testing air, surfaces, and personnel.
• Conduct microbial limit tests, BET, sterility testing etc. of water, API's and KSM's.
• Support cleaning validation by performing swab/rinse microbiological analysis.
• Conduct microbiological validation studies such as 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.
• 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.
• Ensure calibration and qualification of lab instruments (incubators, autoclaves, laminar airflows, microscopes).
• Train production and quality staff on microbiological hygiene and aseptic practices.
• Contribute to continuous improvement of contamination control strategies.