Microbiologist Consultant
Job in
Bloomington, McLean County, Illinois, 61791, USA
Listed on 2026-09-15
Listing for:
United Pharma Technologies Inc
Full Time
position Listed on 2026-09-15
Job specializations:
-
Healthcare
Medical Science, Data Scientist, Medical Technologist & Lab Technician
Job Description & How to Apply Below
Pharmaceutical Microbiologist Consultant Position Summary
Seeking an experienced Pharmaceutical Microbiologist Consultant to provide technical oversight and hands-on support for microbiology and aseptic processing activities within a GMP-regulated pharmaceutical environment. The ideal candidate will have strong experience with aseptic processing, media fills/APS, environmental monitoring, microbiological testing, investigations, and GMP documentation.
Key Responsibilities- Provide technical oversight for media fills / Aseptic Process Simulations (APS), including planning, execution, EM monitoring, media handling, and result review.
- Support and oversee Environmental Monitoring (EM) programs, including viable air, surface, personnel, and cleanroom monitoring.
- Perform and/or provide oversight for GMP microbiology testing, including bioburden, microbial enumeration, microbial identification, growth promotion testing, and BET/endotoxin testing.
- Review microbiological data, laboratory records, EM results, media fill documentation, and GMP records.
- Lead or support investigations involving microbial excursions, OOS/OOT results, adverse trends, root-cause analysis, impact assessments, and CAPAs.
- Support contamination-control programs for clean rooms, utilities, equipment, cleaning/disinfection, and aseptic manufacturing operations.
- Assist with microbiological qualification, validation, and process-control activities.
- Develop, review, and revise SOPs, protocols, reports, test methods, and technical documentation.
- Provide technical guidance and training to microbiology and manufacturing personnel.
- Support regulatory inspections, client audits, and internal quality audits.
- Bachelor's degree in Microbiology, Biology, Biological Sciences, or related field.
- 5+ years of pharmaceutical, biotechnology, or GMP-regulated microbiology experience.
- Hands-on experience with:
- Media fills / Aseptic Process Simulation (APS)
- GMP microbiology laboratory operations
- Bacterial Endotoxin Testing (BET)
- Microbiological investigations and trending
- GMP documentation and data review
- Working knowledge of USP microbiology requirements, FDA regulations, cGMP, aseptic processing, and contamination control.
- Strong technical writing, investigation, documentation, and communication skills.
- Ability to collaborate with Manufacturing, QA, Validation, Engineering, and Quality teams.
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