Microbiologist

Position Summary

The Microbiologist supports the Quality Control Microbiology laboratory by performing routine and non-routine microbiological testing, environmental monitoring, personnel monitoring, and method validation activities. This role is essential for ensuring product sterility, environmental control, and compliance with cGMP, GLP, and regulatory standards. The Microbiologist works closely with cross-functional teams to support investigations, maintain testing readiness, and uphold Medivant’s quality and safety standards.

Microbiologist

• Perform microbiological testing on raw materials, finished products, in-process samples, and environmental samples.
• Conduct routine assays including sterility testing, endotoxin testing, microbial limits testing, bioburden, and growth promotion.
• Execute environmental monitoring (viable & non-viable) and personnel monitoring activities in controlled cleanroom environments.
• Interpret test results, analyze data, and document findings clearly and accurately per GDP requirements.
• Ensure full compliance with GMP, GLP, GDP, FDA, USP, and internal quality standards.
• Maintain, calibrate, and troubleshoot microbiology laboratory equipment (e.g., incubators, LAL systems, biological safety cabinets).
• Assist with development, qualification, and validation of microbiological testing methods and protocols.
• Participate in investigations related to OOS, OOT, deviations, and environmental excursions; support CAPA processes.
• Collaborate with R&D, Production, and Quality Assurance teams to support product development and regulatory compliance.
• Maintain accurate laboratory documentation and support internal/external audits as required.
• Stay current with advancements in microbiology, regulatory updates, and new testing technologies.

• Bachelor’s degree in microbiology, Biology, or a related life science field.
• Minimum 1-3 years of experience in microbiological testing within a pharmaceutical or healthcare industry setting.
• Strong knowledge of microbiological testing methods and laboratory equipment.
• Experience with sterility testing, endotoxin testing, microbial enumeration, environmental monitoring, and personnel monitoring.
• Familiarity with GMP, GLP, FDA, USP, and regulatory quality standards.
• Excellent analytical, organizational, and problem-solving skills.
• Strong attention to detail and accuracy in laboratory practices.
• Ability to work independently and collaboratively in a fast-paced environment.

• Master’s degree in microbiology or related field.
• Experience with advanced microbiological techniques such as PCR, ELISA, and microbial identification systems.
• Experience working in sterile injectable or aseptic manufacturing environments.

• Full-time onsite role in QC Microbiology laboratory and controlled cleanroom areas.
• Ability to stand for extended periods and perform repetitive laboratory tasks.
• May require lifting up to 25 lbs associated with laboratory materials or equipment.
• Requires proper PPE, including lab coats, gloves, safety glasses, and aseptic gowning when entering classified areas.