Microbiologist Consultant

Job Title: Microbiologist ConsultantLocation: Mundelein, ILPosition SummaryThe Pharmaceutical Microbiologist is responsible for providing technical oversight and support for pharmaceutical microbiology activities in a GMP-regulated environment.The position requires a minimum of 5 years of relevant experience in pharmaceutical or biotechnology microbiology, with demonstrated hands-on knowledge of aseptic processing, environmental monitoring, media fill operations, and microbiological laboratory testing.The individual will provide technical oversight of microbiology operations, review microbiological data and investigations, and ensure activities are performed in accordance with approved procedures, regulatory requirements, and current Good Manufacturing Practices (cGMP).Key ResponsibilitiesProvide microbiological oversight and technical support for aseptic processing and media fill (aseptic process simulation) media and EM agar plates activities, including planning, execution, monitoring, and review of results.Oversee and support routine Environmental Monitoring (EM) programs, including viable air, surface, personnel, and other microbiological monitoring activities.Support operation of a standard GMP microbiology laboratory, including microbial enumeration, bioburden testing, microbial identification, growth promotion testing, and related microbiological testing.Perform and/or provide technical oversight for bacterial endotoxin testing (BET) in accordance with applicable compendial requirements.Review microbiological laboratory records, EM results, media fill documentation, test results, and associated GMP documentation.Evaluate microbial excursions, adverse trends, out-of-specification (OOS) and out-of-trend (OOT) results.Lead or support microbiological investigations, root-cause analysis, impact assessments, and CAPA development.Support establishment and evaluation of microbiological alert and action levels and routine data trending.Provide microbiological support for cleanrooms, controlled environments, utilities, equipment, cleaning and disinfection programs, and contamination-control activities.Assist with qualification and validation activities involving microbiological controls and testing.Develop, review, and revise microbiology SOPs, protocols, reports, test methods, and technical documentation.Provide technical guidance and training to microbiology laboratory and manufacturing personnel.Support regulatory inspections, client audits, and internal quality audits involving microbiological and aseptic-processing operations.Minimum QualificationsBachelor's degree in Microbiology, Biology, Biological Sciences, or a related scientific discipline.Minimum 5 years of pharmaceutical, biotechnology, or other GMP-regulated microbiology experience.Demonstrated experience with media fills / aseptic process simulations, environmental monitoring programs, GMP microbiology laboratory operations, bacterial endotoxin testing, microbiological investigations and data trending, and GMP documentation and laboratory data review.Working knowledge of applicable USP microbiological chapters, FDA requirements, cGMP regulations, and industry expectations for aseptic processing and contamination control.Strong technical writing, investigation, documentation, and communication skills.Ability to work directly with Manufacturing, Quality Assurance, Validation, Engineering, and other cross-functional teams.Preferred ExperienceExperience providing lead or supervisory oversight of microbiology operations, including coordination of laboratory activities, media fills, environmental monitoring, investigations, and contamination-control programs, is preferred.