KB Microbiologist I

Amneal • Chicago, IL

8d

About The Position

This employee supports the Microbiology and Environmental Monitoring (EM) department in implementing and managing site microbiology and EM programs, as well as microbiology laboratory operations, to ensure compliance with current regulations. The position interacts directly with manufacturing processes for biological non-sterile drug substance and sterile drug product and requires qualification in aseptic gowning.

The role performs environmental and utility monitoring, microbiological testing, sample handling, visual inspections, and results entry for trend analysis. It also involves work in office and laboratory settings, including aseptic gowning and use of personal protective equipment when exposure to hazardous chemicals or equipment may occur.

Requirements

• Bachelor’s degree in microbiology, biology, or a related discipline.
• Good written and verbal communication skills.
• Good organizational skills and attention to detail.
• Ability to manage time effectively to complete assignments.
• Familiarity with Microsoft Excel and Microsoft Word.
• Ability to work wearing full aseptic gowning for at least four hours once weekly.
• Ability to lift up to 25 lbs.

Nice To Haves

• 0–2 years of experience in a cGMP pharmaceutical manufacturing environment is preferred.

Responsibilities

• Perform environmental monitoring of Kashiv-controlled and aseptic manufacturing areas.
• Collect samples for viable surface, gowning, and air particles, and for non-viable air particles.
• Incubate viable samples; streak representative EM isolates and send them to a contract laboratory for identification.
• Receive test results and enter data for trend analysis.
• Maintain annual gowning qualification.
• Perform sanitation and temperature verification of laboratory refrigerators and incubators.
• Monitor water for injection (WFI), reverse osmosis (RO), purified water (PW), and clean steam (CS) systems.
• Submit samples for TOC, conductivity, microbial count, and endotoxin testing by the microbiology or a contracted laboratory.
• Monitor compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, and moisture.
• Perform bacterial endotoxin testing of WFI, CS, in-process control (IPC), intermediate product (IP), drug substance (DS), and drug product (DP) samples.
• Perform gram stains and growth promotion tests.
• Perform bioburden and microbial limit tests.
• Visually inspect microbiological and EM samples and media fill units.
• Enter results in Excel for trend analysis.
• Perform other tasks as requested by management.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award.
• Long-term incentive award, such as restricted stock units.
• Health and insurance benefits for eligible positions.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level