Job Description
Primary Job Title:
Sterilization Microbiologist
Alternate/Related Job Titles:
Microbiologist – Medical Device Sterilization
Microbiology Process Quality Specialist
Sterilization and Microbiology Laboratory Engineer
Location:
Plymouth, MN
Onsite Flexibility:
Onsite
Contract Details:
Position Type: Contract
Contract Duration: 3.5 months
Start: 09/15/2025
End: 12/31/2025
Pay Rate: $42.33/hour
Shift/Hours: Standard business hours
Job Summary:
The Sterilization Microbiologist applies microbiological concepts to medical device manufacturing, ensuring microbiological quality of the final product. This role involves developing process monitoring metrics, managing controlled access environments, supporting facility operations, and guiding sterilization procedures to meet regulatory requirements. The position also provides technical leadership for microbiological testing, documentation, and quality assurance while collaborating across teams to maintain compliance and process excellence.
Key Responsibilities:
Facility and Routine Production Microbiological Support:
Develop and maintain controlled access environments and associated gowning requirements.
Create and oversee qualifications, specifications, and environmental disturbance reports.
Develop and execute water and compressed air system qualifications and specifications.
Guide cleaning processes and chemical use.
Provide technical support for environmental monitoring and microbiological method issues.
Assess manufacturing process changes for microbial impact.
Technical Sterilization and Microbiological Laboratory Support:
Develop sterilization parameters based on device and packaging design.
Troubleshoot sterilization cycle nonconformances and perform annual validations for ethylene oxide and steam sterilization per regulations.
Conduct product sterilization and adoption processes.
Perform mathematical sterilization calculations (e.g., lethality, D-value).
Assess sterilization needs for production changes such as process or packaging adjustments.
Ensure compliance with reusable device regulatory requirements.
Develop and validate microbiological test methods, train laboratory staff, and review test reports.
Mentor microbiology staff and provide technical expertise.
Investigate calibration out-of-tolerance events.
Documentation and Technical Writing:
Apply applicable standards to qualification and testing procedures.
Write protocols and reports for:
Controlled access environments, compressed air systems, and water systems
Microbiological test methods
Sterilization validations and product adoptions
Equipment qualifications
LAL sampling and analysis
Develop laboratory procedures, product monitoring protocols, and incoming component specifications.
Quality Assurance Support:
Review and release sterile loads.
Support supplier change notifications and review FMEAs.
Review and approve nonconforming material reports.
Serve as a subject matter expert for supplier and internal/external audits.
Other Responsibilities:
Participate in R&D and operations project teams as assigned.
Support company initiatives under QMS, EMS, and other regulatory frameworks.
Comply with FDA and other regulatory requirements.
Maintain positive, cooperative relationships across all organizational levels.
Required Experience:
Bachelor’s degree with 5+ years in medical device, pharmaceutical, or related industry.
Hands-on experience in microbiology and/or sterilization in a regulated lab environment.
Proven troubleshooting skills for complex sterilization or contamination issues.
Nice-to-Have Experience:
Experience in cross-divisional enterprise environments.
Ability to work independently in fast-paced, matrixed organizations.
International travel experience (5–25%).
Required Skills:
Strong microbiology and sterilization process knowledge.
Expertise in environmental monitoring and controlled environment management.
Proficiency in technical writing and protocol/report preparation.
Preferred Skills:
Experience mentoring and training technical staff.
Knowledge of reusable device regulations.
Mathematical sterilization calculation skills.
Additional Skills:
Strong verbal and written communication skills.
Ability to multitask, prioritize, and meet deadlines.
Organizational skills with attention to detail.
Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About the Client:
Manufacturer of advanced medical devices committed to patient safety, innovation, and compliance. This facility integrates cutting-edge microbiology and sterilization techniques to ensure the highest product quality standards.
About GTT:
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!
Job Number: 25-24660 #gttic
Job Tags
Contract work, Shift work,