Microbiologist

Position Overview

We are seeking a Microbiologist to support the Microbiology and Environmental Monitoring (EM) department, contributing to the implementation and management of site microbiology and EM programs as well as overall microbiology laboratory operations to ensure compliance with current regulations. This role involves direct interaction with manufacturing processes related to biological non-sterile drug substance and sterile drug product. Qualification in aseptic gowning is required for this position.

Essential Duties & Responsibilities

• Performs environmental monitoring of controlled and aseptic manufacturing areas
• Collects samples for detection of viable (surface, gowning, and air) and non-viable (air) particles
• Incubates viable samples
• Streaks and sends representative EM isolates to a contract laboratory for identification; receives results and performs data entry for trend analysis
• Complies with annual gowning qualification requirements
• Performs sanitation and temperature verification of laboratory refrigerators and incubators
• Performs routine monitoring for water for injection (WFI), reverse osmosis (RO), purified water (PW), and clean steam (CS) systems
• Submits samples for testing (TOC, conductivity, microbial count, endotoxins) to microbiology laboratory or contracted laboratory
• Performs routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, and moisture
• Performs bacterial endotoxin testing of WFI, CS, in-process control (IPC), intermediate product (IP), drug substance (DS), and drug product (DP) samples
• Performs gram stain and growth promotion testing
• Performs bioburden and microbial limit testing
• Performs visual inspection of microbiological and EM samples and media fill units

Position Requirements and Qualifications

Education: Bachelor's degree in microbiology, biology, or a related science field required

Experience: 0-2 years of experience in a cGMP pharmaceutical manufacturing environment preferred; open to candidates with relevant experience from food, pharma, or medical device industries

Location

Onsite in Chicago, IL

Compensation

$58,000 - $60,000 annually

Schedule

This role supports a manufacturing operation, so hours are not a fixed Monday through Friday, 8-5 schedule. Flexibility is required, including occasional early starts, late finishes, and weekend coverage (Saturday and/or Sunday) depending on the production schedule. Weekly schedules are typically confirmed by Friday for the following week and are dependent on manufacturing timelines and any delays. Some weeks may include 5-10 hours of overtime.