Novartis
MicrobiologySpecialist
Neural analysis suggests this role is
optimal for Mid candidates.
“Microbiology Specialist at Novartis. Skills: microbiological testing, method verification, environmental monitoring, Good Manufacturing Practice, Good Documentation Practice, Good Laboratory Practice. 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”
What You'll Achieve.
ensuring the quality, safety, and integrity of our products; contributing directly to Novartis’ mission to deliver high-quality medicines to patients worldwide
Industry & Context.
Problem Solving Skills; investigations; deviations; change controls
Ability to gown for entry into aseptic areas, lift approximately 25 pounds
What They're Looking For.
Must Have
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, 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
What You'll Do.
Perform microbiological qualification
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
and trending of critical reagents
and microbiology controls
Review and approve routine and transfer data
supporting deviations
and quality investigations
Coordinate environmental monitoring performance qualification
and utilities qualification activities
Perform microbiological testing of materials
and environmental and personnel monitoring samples
Analyze trends and performance indicators while supporting sample planning and execution across laboratory activities
How You'll Work.
Team & Collaboration
Partner closely with cross-functional teams to support investigations, qualifications, and continuous improvement initiatives
Communication Scope
Communication Skills
Full Job Description
**Band** Level 3 **Job Description Summary** 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 shift, 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. **Job Description** ## Key responsibilities: * 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 microb
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