Microbiologist

Microbiologist Location: Mundelein, IL Position SummaryWe are seeking four Pharmaceutical Microbiologist Consultants to provide technical oversight and hands-on support for microbiology activities within a GMP-regulated pharmaceutical or biotechnology environment.The ideal candidate will have a minimum of 5 years of relevant pharmaceutical or biotechnology microbiology experience, with strong hands-on knowledge of aseptic processing, media fills/aseptic process simulations, environmental monitoring, microbiological laboratory testing, investigations, and GMP documentation. Key ResponsibilitiesProvide microbiological oversight and technical support for aseptic processing and media fill (aseptic process simulation) activities, including planning, execution, monitoring, and review of results.Support media fill media and EM agar plate activities and associated documentation.Oversee routine Environmental Monitoring (EM) programs, including viable air, surface, personnel, and other microbiological monitoring activities.Support GMP microbiology laboratory operations, 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 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 perform 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.Collaborate with Manufacturing, Quality Assurance, Validation, Engineering, and other cross-functional teams. Minimum QualificationsBachelor's degree in Microbiology, Biology, Biological Sciences, or a related scientific discipline.Minimum 5 years of pharmaceutical, biotechnology, or GMP-regulated microbiology experience.Hands-on experience with:Media fills / Aseptic Process Simulations (APS)Environmental Monitoring (EM) programsGMP microbiology laboratory operationsBacterial Endotoxin Testing (BET)Microbiological investigations and data trendingGMP documentation and laboratory data reviewWorking knowledge of applicable USP microbiological chapters, FDA requirements, cGMP regulations, aseptic processing, and contamination-control expectations.Strong technical writing, investigation, documentation, and communication skills.Ability to work effectively with Manufacturing, Quality Assurance, Validation, Engineering, and cross-functional teams. Preferred ExperienceExperience providing lead or supervisory oversight of microbiology operations.Experience coordinating laboratory activities, media fills, environmental monitoring, investigations, and contamination-control programs.Experience working in highly regulated pharmaceutical or biotechnology manufacturing environments.