Microbiology Specialist

Job Description Summary

Job Description

• 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.

• 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.

The salary for this position is expected to range between $43.07/hour and $80.00/hour. The final salary offered is determined based on factors such as relevant skills, experience, and market considerations, and will be reviewed periodically upon joining Novartis. Novartis may adjust the published salary range based on company and market factors. Compensation includes eligibility for a performance-based incentive.

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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired