Microbiologist

The Microbiologist supports microbiology and environmental monitoring (EM) programs while ensuring compliance with cGMP regulations. This role involves hands-on laboratory work and collaboration with manufacturing processes for non-sterile and sterile products.

Key Responsibilities

• Perform environmental monitoring in controlled and aseptic manufacturing areas, collecting samples for viable and non-viable particle detection.
• Conduct routine water and steam system monitoring (WFI, RO, PW, CS) for TOC, conductivity, microbial counts, and endotoxins.
• Execute bacterial endotoxin testing, gram staining, growth promotion, bioburden, and microbial limit testing.
• Monitor and verify laboratory equipment, including refrigerators and incubators.
• Record and review microbiology data, conducting trend analysis in Excel.
• Investigate deviations, including OOS and EM Action/Alert Levels, and implement corrective actions.
• Support aseptic gowning qualifications and adhere to GMP protocols in all operations.
• Perform compressed air and nitrogen gas monitoring for particles, oil, and moisture.

Qualifications

Education:

• Bachelor’s degree in microbiology, biology, or a related field.

Experience:

• 1+ years of experience in a cGMP pharmaceutical manufacturing environment.
• Knowledge of cGMP regulations (21 CFR 201/211/820).

Skills:

• Proficiency with air sampling equipment, including AirIdeal, HACH Met Ones, and Lasair III.
• Strong organizational skills, attention to detail, and ability to manage time effectively.
• Familiarity with Microsoft Excel and Word for documentation and analysis.

Work Environment & Physical Demands

• Laboratory and manufacturing settings, requiring aseptic gowning for up to 4 hours weekly.
• Flexibility to work weekends, holidays, or extended hours as needed.
• Ability to lift up to 25 lbs.

This position is ideal for candidates with foundational experience in microbiology who are looking to grow in a cGMP-compliant manufacturing environment.