Microbiologist Consultant

Pharmaceutical Microbiologist Consultant

Location: Mundelein, IL | OnsitePosition SummarySeeking 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 ResponsibilitiesProvide 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 cleanrooms, 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.Required QualificationsBachelor’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)Environmental MonitoringGMP microbiology laboratory operationsBacterial Endotoxin Testing (BET)Microbiological investigations and trendingGMP documentation and data reviewWorking 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.