Microbiology Specialist I

Job Summary

Key Responsibilities

• Perform routine environmental monitoring of classified cleanrooms during operational and non-operational conditions.
• Collect and process environmental samples including air, surface, and personnel monitoring.
• Conduct microbiological testing of media, utilities, raw materials, and in-process samples.
• Identify microbial isolates using established laboratory procedures.
• Support investigations involving environmental monitoring excursions and microbiological deviations.
• Review, document, and maintain laboratory records in accordance with GMP requirements.
• Assist with laboratory equipment calibration, maintenance, inventory, and housekeeping activities.
• Compile environmental monitoring data, perform trend analysis, and prepare routine reports.
• Absorb and update SOPs, protocols, and laboratory documentation.
• Participate in internal audits, training activities, and continuous process improvement initiatives.

Education and Experience

• Bachelor's degree in microbiology, Biology, Biotechnology, Life Sciences, or a related scientific discipline preferred.
• Relevant industry experience may be considered in lieu of a degree.
• 1-3 years of experience in microbiology, environmental monitoring, or quality control laboratory operations.
• Experience working in GMP-regulated pharmaceutical, biotechnology, or medical device environments preferred.
• Familiarity with cleanroom practices, aseptic techniques, and microbiological testing methods.
• Strong documentation skills and knowledge of GMP documentation practices.
• Ability to work independently and collaboratively in a laboratory environment.