Microbiologist job description

Job brief

We are seeking a precise and analytical Microbiologist to join our Quality Control team and oversee the biological safety of our sterile manufacturing lines. In this role, you will lead environmental monitoring programs, evaluate microbial purity of raw materials, and act as a technical subject matter expert during regulatory audits. You will play a vital part in our mission to deliver life-saving medications by ensuring every batch conforms to USP, EP, and JP pharmacopeia requirements. If you are passionate about aseptic technique and microbiological risk mitigation, we invite you to advance your career with us.

What is a Microbiologist?

A Microbiologist serves as a critical guardian of pharmaceutical product integrity, conducting rigorous microbial testing and environmental monitoring to prevent contamination. By leveraging advanced analytical techniques such as rapid microbial methods and MALDI-TOF identification, a Microbiologist ensures that drug substances and finished products meet stringent safety standards. Their expertise in managing bioburden, endotoxin, and sterility testing is essential for maintaining the quality systems required to protect patient health in the life sciences sector.

What does a Microbiologist do?

On a daily basis, a Microbiologist performs aseptic processing oversight, monitors cleanroom environments for viable and non-viable particulates, and conducts microbial identification using DNA sequencing or biochemical assays. They operate laboratory instrumentation like VITEK systems or BacT/ALERT systems while documenting all findings in LIMS for regulatory submission. This role involves frequent collaboration with Quality Assurance and Manufacturing teams to investigate Out-of-Specification (OOS) results, implement CAPA measures, and support facility re-qualification efforts to maintain a state of compliance.

Key responsibilities

• Execute sterility testing, bioburden analysis, and endotoxin monitoring for drug products in accordance with current USP and EP compendial methods.
• Perform routine environmental monitoring of Grade A/B cleanrooms, including surface, air, and personnel sampling to ensure compliance with cGMP standards.
• Conduct microbial identification of isolates using MALDI-TOF or 16S rRNA gene sequencing to perform accurate root cause analysis and trend reporting.
• Manage and maintain accurate laboratory records within our LIMS environment to ensure full audit readiness and data integrity for all tests performed.
• Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) microbiology laboratory results by leading technical reviews and authoring comprehensive deviation reports.
• Develop and validate new microbial test methods, including suitability testing and growth promotion verification, to support drug development and scale-up.
• Coordinate with cross-functional quality and engineering teams to identify contamination sources and implement robust CAPA or mitigation strategies.
• Review and approve technical documentation and Standard Operating Procedures (SOPs) to ensure alignment with evolving FDA and EMA regulatory guidelines.

Requirements and skills

• Bachelor's or Master's degree in Microbiology, Biology, or a related life sciences discipline from an accredited institution.
• 3+ years of experience performing microbiological laboratory testing within a cGMP-regulated pharmaceutical or biotechnology environment.
• In-depth knowledge of USP, EP, and JP pharmacopeia, as well as FDA and EMA regulations regarding sterile pharmaceutical manufacturing.
• Proven proficiency in aseptic techniques and the operation of lab instrumentation such as VITEK 2, Millipore filtration systems, or rapid microbial methods.
• Strong technical writing skills demonstrated by the ability to author, review, and maintain GMP documentation and SOPs effectively.
• Ability to communicate complex microbiological risk assessments clearly to Quality Assurance and operations leadership during audit scenarios.
• Experience utilizing LIMS or similar electronic data management platforms to ensure data integrity and track laboratory performance metrics.
• Professional certification in Medical Laboratory Science (ASCP) or related microbiology credentials is highly preferred but not required.

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