Microbiologist

Position Summary

Stevanato is hiring a Microbiologist to join our growing quality team!

The Microbiologist will be responsible for conducting microbiological testing, ensuring compliance with regulatory standards, and supporting the development and manufacturing processes for medical devices and pharmaceutical products. This role requires expertise in microbiology, a commitment to quality, and the ability to work collaboratively in a fast-paced, regulated environment.

• Microbiological Testing and Analysis
  :
  Perform sterility testing, bioburden analysis, endotoxin testing, and environmental monitoring to ensure product safety.
• Quality Assurance
  :
  Implement and maintain microbiological quality control systems in compliance with FDA, ISO, and other applicable regulatory standards.
• Process Validation
  :
  Support sterilization validation, cleanroom qualification, and microbiological risk assessments.
• Documentation and Reporting
  :
  Maintain accurate records of test results, investigations, and compliance reports; ensure proper documentation per Good Manufacturing Practices (GMP).
• Compliance Monitoring
  :
  Monitor adherence to aseptic techniques and provide recommendations for corrective actions as needed.
• Problem Solving
  :
  Investigate microbiological deviations and non-conformances, propose root cause analyses, and implement corrective and preventive actions (CAPAs).

Education and Experience
:

• Bachelor’s or Master’s degree in Microbiology, Biology, or a related field.
• 2+ years of relevant experience in microbiology within the medical device or pharmaceutical industry.

Technical Skills
:

• Proficiency in microbiological testing methods and equipment (e.g., autoclaves, incubators, microscopes).
• Knowledge of regulatory requirements (FDA, USP, ISO 13485, cGMP).
• Experience with cleanroom environments and aseptic techniques.
• Familiarity with sterilization processes, such as ethylene oxide (EtO) or gamma irradiation.

• Brand new facility located in the Fishers Life Sciences and Innovation Park
• Cafeteria onsite serving breakfast, lunch, and snacks - employees get a daily meal stipend
• 100% employer paid Dental and Vision benefits
• Modern space with brand new technology, climate-controlled production floor
• Opportunity for growth, development, and advancement
• 3 weeks of PTO, 10 paid holidays, 8 sick days