Pharmaceutical Microbiologist

Job Title: Pharmaceutical Microbiologist
Location
:
Mundelein, Illinois
Minimum Experience: 5 years Industry
Pharmaceutical / Biotechnology
Position Type: Microbiology / Quality Operations

The 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).

Provide 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-oftrend (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 clean rooms, 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 Qualifications:
Bachelor's degree in Microbiology, Biology, Biological Sciences, or a related scientific discipline.
Minimum 5 years of pharmaceutical, biotechnology, or other GMP-regulated microbiology experience.

Media fills / aseptic process simulations
Environmental monitoring programs
GMP microbiology laboratory operations
Bacterial endotoxin testing o Microbiological investigations and data trending
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.

Experience providing lead or supervisory oversight of microbiology operations, including coordination of laboratory activities, media fills, environmental monitoring, investigations, and contamination-control programs, is preferred