Microbiologist

Job Overview

The role involves executing microbiological evaluations and environmental surveillance to uphold compliance with current Good Manufacturing Practices (cGMP), pharmacopeial criteria, and pharmaceutical quality standards. Responsibilities include water system analysis, culture media preparation, microorganism detection, and laboratory maintenance.

Key Duties

• Carry out environmental surveillance through air and surface sampling coupled with trend analyses.
• Test microbiological quality of purified water, water for injection, and other utilities.
• Prepare and sterilize culture media, performing growth promotion tests to ensure efficacy.
• Execute microbial limit tests, bioburden assays, bacterial endotoxin evaluation, and identification of specific microorganisms on raw materials, packaging, in-process samples, and final products.
• Conduct laboratory analyses including disinfectant preparation and testing of compressed air and gases.
• Investigate incidents related to Out of Specification (OOS), Out of Trend (OOT) results, and environmental deviations, contributing to Corrective and Preventive Actions (CAPA).
• Maintain laboratory instruments, documentation, and data integrity adhering to GMP and ALCOA+ standards.

Required Qualifications

• Bachelor's degree in Microbiology, Biology, or a closely related scientific discipline.
• Preferred familiarity with pharmaceutical microbiology, manufacturing workflows, and cGMP protocols.
• Excellent communication, analytical ability, and interpersonal skills.
• Capability to collaborate effectively within cross-functional teams.