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Sterilization Microbiologist
Contract: Plymouth, Minnesota, US span>
Salary Range: 25.00 - 32.00 | Per Hour
Job Code: 367108
End Date: 2026-02-06
Job Status: Expired
This Job is no longer accepting applications
Position Details:
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
Job Responsibilities:
- Perform a desk-based role with no hands-on laboratory or cleanroom work required.
- Review and interpret cleanroom monitoring results, including:
- Non-viable particle counts
- Viable active air monitoring
- Viable surface monitoring
- Pressure differentials and alarms
- HEPA airflow and velocity
- Electronically review routine test results in LIMS, including:
- Environmental monitoring data
- Product bioburden results
- Product endotoxin results
- 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:
- Product bioburden
- Bacterial endotoxin
- Sterilization processes
- 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.
Qualifications:
- 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 cleanrooms (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.
Benefits:
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 , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).
Job Requirement
- Cleanroom
- Environmental Monitoring
- Microbiology
- Quality Support
- Desk-Based Role
- ISO 8
- ISO 9
- Bioburden
- Endotoxin
- Endotoxin Testing
- Non-Viable Particles
- Viable Air Monitoring
- Surface Monitoring
- Pressure Differential
- HEPA Velocity
- Environmental Disturbances
- Out-of-Specification Investigations
- Root Cause Analysis
- LIMS
- Data Review
- Documentation
- Technical Reports
- Supplier Change Notification (SCN)
- Environmental Disturbance Reports (EDR)
- Sterilization Support
- Medical Device Manufacturing
- Pharmaceutical Manufacturing
Reach Out to a Recruiter
- Recruiter
- Phone
- Siddhi Kadakia
- siddhi.kadakia@collabera.com