Sterilization Microbiologist

Overview

Client:
Medical Devices Company

Position Title:

Sterilization Microbiologist
Duration: 12 months (Possible extension)

Location:

Plymouth, MN 55442
Pay Range: 25.00 to 32.00 per hour

• Perform a desk-based role with no hands-on laboratory or cleanroom work required.
• Review and interpret cleanroom monitoring results, including:
• Pressure differentials and alarms
• HEPA airflow and velocity
• Electronically review routine test results in LIMS, including:
• Document and investigate cleanroom monitoring excursions when results do not meet specifications.
• Document and investigate environmental disturbances within cleanroom environments (e.g., pressure differential excursions).
• Document and investigate product bioburden and endotoxin excursions, including identification of potential root causes.
• Support Supplier Change Notifications (SCN) by evaluating supplier-initiated changes and assessing potential impact to:
• Support changes to the manufacturing environment by authoring Environmental Disturbance Reports (EDRs) for planned activities such as:
• Adding equipment
• Adding tables or personnel
• Other manufacturing layout or process changes
• Author technical reports for acceptable results and ensure accurate documentation and approvals.
• Conduct cross-functional investigations and discussions with Engineers, Production Supervisors, and other stakeholders (e.g., via MS Teams).
• Focus on data review, investigation, documentation, and approval activities only.
• Provide biological support to sterilization-related activities (no hands-on sterilization work).
• After initial training, work independently with minimal oversight and take ownership of assigned investigations.

• Bachelor’s degree in Microbiology, Biology, Life Sciences, or a related scientific field plus 1+ year of relevant experience, or an equivalent combination of education and experience.
• Knowledge of medical device manufacturing and cleanroom environments.
• Familiarity with ISO Class 6-9 clean rooms (ISO 8 and ISO 9 preferred).
• Basic working knowledge of bioburden and endotoxin testing, including common causes of elevated results.
• Endotoxin testing experience is highly preferred.
• LIMS experience is helpful but not required (training will be provided).
• Strong analytical, documentation, and investigation skills.
• Ability to work confidently, independently, and manage investigations once trained.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, paid vacation, paid parental leave, and paid holidays annually. Eligibility applies.