Microbiologist

About the role

The Microbiologist will operate in compliance with hygiene, safety, quality, and regulatory standards, and align with the organization's framework, company procedures, and defined responsibilities.

Responsibilities

• Perform routine microbiological testing, including microbial bioburden, endotoxin (gel clot and kinetic turbidimetric), sterility testing, particulate matter analysis, and container closure integrity testing on raw materials, in-process samples, finished products, and components.
• Support environmental monitoring (EM) programs by conducting viable air, surface, and personnel sampling, as well as non-viable particulate monitoring using standard laboratory equipment.
• Collect and test facility water and clean steam samples for microbial bioburden and endotoxin, and submit samples for additional chemical analysis (e.g., TOC, conductivity).
• Accurately document, enter, and review laboratory data in LIMS, ensuring compliance with data integrity standards.
• Assist in trending microbiological data, identifying atypical results, and escalating potential issues to senior staff.
• Perform investigations, including out-of-specification (OOS) results and minor deviations, and assist with CAPA activities as needed.
• Perform general laboratory duties such as equipment operation (autoclave, glassware washer), sample receipt and reconciliation, waste disposal, and maintenance of laboratory records.
• Participate in peer review of data and ensure all testing documentation is complete and compliant with SOPs and regulatory requirements.
• Follow established procedures and aseptic techniques while maintaining a clean and organized laboratory environment.
• Provide basic support and knowledge sharing to peers as directed and continue to build technical expertise.

Requirements

• Required Qualifications:
• Bachelor’s degree in Microbiology, Biology, or a related life science.
• Hands-on experience with microbiological techniques, including environmental monitoring, endotoxin testing (kinetic LAL and gel clot), filtration testing, particulate matter testing, and sterility testing.
• Knowledge of aseptic techniques and cleanroom practices.
• Basic proficiency in Microsoft Office (Excel, PowerPoint, Access).
• Strong attention to detail with the ability to follow standard operating procedures and document results accurately.
• Effective communication skills and ability to work collaboratively with team members and cross-functional groups.
• Preferred Qualifications:
• Prior laboratory experience, preferably in the pharmaceutical or regulated industry.
• Experience operating laboratory equipment such as autoclaves and glassware washers.
• Familiarity with investigation writing and deviation documentation.
• Ability to train or mentor other personnel on procedures and techniques.