Microbiology Specialist

Key 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.

Essential 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.

Novartis Compensation and Benefit Summary

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.