Associate Microbiologist

Responsibilities

• Conduct routine and specialized microbiological testing, including sterility, bioburden, endotoxin, and environmental monitoring.
• Ensure microbiological activities comply with FDA regulations, ISO standards, and internal quality system requirements.
• Support sterilization validations, cleanroom qualifications, and microbiological risk assessments.
• Maintain accurate and timely documentation of test results, investigations, and reports in accordance with GMP standards.
• Monitor aseptic practices within controlled environments and provide feedback or recommendations to improve compliance.
• Investigate microbiological deviations, perform root cause analyses, and assist with the implementation of corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams to support manufacturing, quality, and process improvement initiatives.

Qualifications:

• Bachelor’s or Master’s degree in Microbiology, Biology, or a related scientific discipline.
• Minimum of two (2) years of relevant microbiology experience in a pharmaceutical, biotech, or medical device environment.
• Proficiency with microbiological testing methods and laboratory equipment such as autoclaves, incubators, and microscopes.
• Working knowledge of regulatory requirements including FDA, USP, ISO 13485, and cGMP.
• Experience working in cleanroom environments and applying aseptic techniques.
• Familiarity with sterilization processes such as ethylene oxide (EtO) and gamma irradiation is preferred.