Microbiology Laboratory Technician

Job Title: Microbiology Laboratory TechnicianLocation: Round Lake, ILWork Schedule: First Shift – Thursday through Monday
Job SummaryThis role involves microbiological testing of raw materials, in-process samples, and finished pharmaceutical products, including biologics and drugs. Responsibilities also include environmental and critical utility monitoring, laboratory investigations, and maintaining compliance with cGMP, FDA regulations, and company procedures.
ResponsibilitiesPerform microbiological testing of incoming raw materials, in-process samples, finished products, and environmental monitoring samples.Conduct routine environmental monitoring, including surface, air, particulate, and personnel monitoring.Perform microbiological monitoring of critical systems, including water, clean steam, process compressed air, and nitrogen.Prepare laboratory media and reagents and operate laboratory instruments such as particle counters, pH meters, SAS air samplers, and autoclaves.Use Laboratory Information Management Systems (LIMS) and other computer systems to collect, document, review, and maintain accurate laboratory data.Monitor laboratory inventory, manage supplies and reagents, and maintain a clean, safe, and organized laboratory environment.Conduct and document laboratory investigations and nonconformance reports, including root cause analysis, impact assessments, and corrective and preventive actions (CAPA).Ensure data integrity and compliance with cGMP, GLP, FDA regulations, Quality System Regulations (QSR), and company SOPs.Follow established safety procedures and support additional laboratory activities and projects as assigned.Work in both Drug Delivery and Penicillin manufacturing facilities as required.
Requirements:Bachelor’s degree in Microbiology, Biological Sciences, or a related field.Minimum of 2 years of experience in a laboratory setting.Basic knowledge of microbiology, biology, and aseptic techniques.Proficiency in Laboratory Information Management Systems (LIMS).Strong attention to detail, reading comprehension, documentation, and organizational skills.Ability to manage multiple tasks efficiently while maintaining accuracy and meeting deadlines.Ability to work independently and collaboratively in a team environment.Strong technical writing skills and the ability to document laboratory activities and investigations.Ability to lift up to 50 pounds when required.Must be able to work in both Drug Delivery and Penicillin facilities and meet applicable facility safety requirements, including assessment of penicillin and cephalosporin allergy risks.
Preferred:Knowledge of Good Laboratory Practices (GLP) and pharmaceutical aseptic processing requirements.Familiarity with cGMP regulations and pharmaceutical quality systems.Experience with root cause investigation methodologies, including DMAIC (Define, Measure, Analyze, Improve, Control).Experience with environmental monitoring and microbiological testing in pharmaceutical or biologics manufacturing environments.
Work Schedule and RequirementsFirst-shift schedule: Thursday through Monday.Occasional off-shift, weekend schedule adjustments, and holiday work may be required.On-site work at the Round Lake, IL manufacturing facility.Must follow all applicable safety procedures, company policies, and laboratory quality standards.