Microbiology Specialist

Novartis • Durham, CA

1d • Onsite

About The Position

If you’re driven by protecting patients through rigorous contamination control and scientific excellence, this is your opportunity to make a meaningful impact every day. As a Microbiology Specialist, you’ll play a critical role in ensuring the quality, safety, and integrity of our products by leading microbiological testing, method verification, and environmental monitoring activities within a highly regulated manufacturing environment. You’ll partner closely with cross-functional teams to support investigations, qualifications, and continuous improvement initiatives, while applying your expertise to data review, trending, and technical documentation. This role offers the chance to work hands-on with advanced microbiology processes, influence site readiness, and serve as a trusted subject matter expert—contributing directly to Novartis’ mission to deliver high-quality medicines to patients worldwide. #LI-Onsite Location: Durham, NC, USA Shift: 1st; 2 positions available This role is based in Durham, NC, USA. Novartis is unable to offer relocation support: please only apply if this location is accessible for you.

Requirements

• Bachelor’s degree in biochemistry, biology, microbiology, or a related scientific discipline.
• Minimum five years of experience working in a Good Manufacturing Practice environment.
• Proven experience performing microbiological testing, including utilities testing and environmental and personnel monitoring.
• Demonstrated ability to write protocols, verification documentation, and technical reports using Good Documentation Practice.
• Experience reviewing and approving laboratory data, supporting deviations, investigations, and change controls.
• Strong knowledge of Good Laboratory Practice and Good Documentation Practice principles.
• Understanding of United States Food and Drug Administration and European Medicines Agency regulatory expectations.
• Ability to gown for entry into aseptic areas and lift approximately 25 pounds.

Responsibilities

• Writing of all protocols and reports for verifications of Microbiology and EM methods into Tricenter for LIVI ADP (bioburden, endotoxin, sterility, EM, Utilities etc).
• Perform microbiological qualification, release, stability, and investigational testing to support compliant manufacturing operations.
• Author and maintain protocols and reports for microbiology and environmental monitoring method verification and validation activities.
• Execute method transfers and verifications for microbiology and environmental monitoring assays across laboratory systems.
• Maintain qualification, control, and trending of critical reagents, standards, and microbiology controls.
• Review and approve routine and transfer data, supporting deviations, change controls, and quality investigations.
• Coordinate environmental monitoring performance qualification, site assessments, media fills, and utilities qualification activities.
• Perform microbiological testing of materials, utilities, and environmental and personnel monitoring samples.
• Analyze trends and performance indicators while supporting sample planning and execution across laboratory activities.

Benefits

• U.S.-based eligible employees will receive a comprehensive benefits package, including health, life, and disability insurance, a 401(k) with company contribution and match, and generous paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees