Microbiologist

Job Description:

The role involves executing microbiological testing and monitoring activities to ensure product and process compliance with established quality standards, while supporting production objectives.

Key Responsibilities:

• Perform routine microbiological assays including environmental monitoring, sterility testing, bioburden analysis, and growth promotion quality (GPQ) assessments.
• Ensure timely and accurate completion of documentation and data entry for routine laboratory tests to meet defined testing cycle times.
• Facilitate training and qualification of microbiological techniques for laboratory personnel.
• Draft and implement new protocols or revise existing procedures to align with regulatory and internal requirements.
• Conduct validation activities for laboratory processes and instrument qualifications, as applicable.
• Review and approve laboratory test reports, data results, and associated documentation within the Laboratory Information Management System (LIMS).
• Lead investigations into laboratory deviations and non-conformances, including out-of-specification (OOS) results, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPA).
• Serve as a Subject Matter Expert (SME) during cross-functional investigations, regulatory inspections, and internal audits.
• Contribute to the development and optimization of laboratory systems and workflows, including gap analyses and process improvements.
• Participate in Continuous Improvement (CI) initiatives to enhance laboratory efficiency and compliance.
• Maintain strict adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Perform periodic analysis and trending of microbiological data to identify patterns and support decision-making.
• Prepare clear and concise reports, emails, and memos for internal and external stakeholders.
• Ensure laboratory readiness for regulatory inspections and customer audits.
• Uphold a safe laboratory environment by complying with all applicable safety standards and regulations.

Minimum Qualifications:

• Bachelor's degree in Microbiology, Biology, or a related scientific discipline.
• 3–5 years of relevant experience in the pharmaceutical industry.
• Prior experience in aseptic processing is advantageous.