Microbiologist I

Position Overview

Our client is seeking a Microbiology / Environmental Monitoring (EM) Technician I/II to support microbiology laboratory operations and environmental monitoring activities within a cGMP pharmaceutical manufacturing facility. This individual will play a key role in ensuring manufacturing areas meet microbiological and environmental quality standards while supporting the production of both sterile drug products and biological non-sterile drug substances.

This position works closely with Manufacturing, so flexibility is essential. While the typical workday is during first shift, schedules vary based on manufacturing needs. Overtime is common and may include early mornings, evenings, weekends, and occasional Saturday/Sunday work. Weekly schedules are finalized based on production demands and communicated on Fridays.

This opportunity is open to both entry-level and experienced candidates. The client is open to candidates from pharmaceutical, medical device, biotechnology, food, or other regulated manufacturing industries.

Responsibilities

• Perform environmental monitoring of controlled manufacturing and aseptic processing areas.
• Collect viable and non-viable environmental monitoring samples, including air, surface, and gowning samples.
• Incubate microbiological samples and prepare isolates for identification by contract laboratories.
• Review identification results and enter data for environmental monitoring trend analysis.
• Maintain annual aseptic gowning qualification requirements.
• Perform routine monitoring of Water for Injection (WFI), Reverse Osmosis (RO), Purified Water (PW), and Clean Steam (CS) systems.
• Collect and submit water samples for microbial count, endotoxin, TOC, and conductivity testing.
• Perform monitoring of compressed air and nitrogen systems for viable particles, non-viable particles, and moisture.
• Conduct bacterial endotoxin testing on raw materials, in-process samples, drug substances, and finished drug products.
• Perform microbiological testing, including gram stains, growth promotion, bioburden, and microbial limit testing.
• Conduct visual inspection of microbiological media, environmental monitoring samples, and media fill units.
• Maintain accurate documentation and perform data entry for trending and reporting purposes.
• Verify laboratory sanitation and monitor refrigerator and incubator temperatures.
• Support additional microbiology laboratory activities as assigned.

Qualifications

• Bachelor's degree in Microbiology, Biology, or another scientific discipline required.
• 0–2 years of experience in a cGMP pharmaceutical manufacturing environment preferred.
• Experience in pharmaceutical, biotechnology, medical device, food manufacturing, or another regulated industry is welcomed.
• Strong attention to detail and documentation skills.
• Comfortable working in aseptic manufacturing environments and obtaining gowning qualification.
• Proficiency with Microsoft Excel for data entry and trending is preferred.
• Strong communication and organizational skills.

Schedule

• Flexible schedule required to support manufacturing operations.
• Typical work occurs on first shift; however, start/end times may vary.
• Weekly schedules are determined based on manufacturing needs.
• Expect approximately 5–10 hours of overtime per week during busy production periods.
• Occasional weekend work (Saturday and/or Sunday) may be required.

Pay

$25-30/hr