
Microbiologist
- Plymouth, MN
- $40.00-55.00 per hour
- Permanent
- Full-time
- Lead qualifications and documentation for controlled access environments, including specifications and disturbance reports.
- Define gowning protocols and oversee water and compressed air system qualifications.
- Provide guidance on cleaning procedures and chemical usage.
- Offer technical support for environmental monitoring and microbiological methods.
- Evaluate the microbial impact of changes in manufacturing processes.
- Establish sterilization parameters based on device and packaging design.
- Troubleshoot issues in routine and validation sterilization cycles.
- Conduct annual validations for ethylene oxide and steam sterilization per regulatory standards.
- Perform sterilization assessments for changes in process, packaging, load configuration, and design.
- Apply mathematical calculations for sterilization (e.g., lethality, D-value).
- Ensure compliance with reusable device regulations.
- Develop and validate microbiological test methods.
- Train lab technicians and review routine test reports.
- Identify and communicate opportunities, risks, and solutions across teams.
- Mentor microbiology staff and provide technical expertise.
- Investigate calibration discrepancies and out-of-tolerance conditions.
- Stay current with applicable standards and apply them to qualifications and testing.
- Author protocols and reports for controlled access environments, compressed air and water systems, microbiological test methods, sterilization validations, and product adoptions.
- Write procedures for lab operations, product monitoring, and component specifications.
- Review and release sterile product loads.
- Support supplier change notifications and review FMEAs.
- Approve nonconforming material reports.
- Serve as a subject matter expert during supplier and internal/external audits.
- Participate in R&D and Operations project teams.
- Support other initiatives as directed by the department.
- Bachelor's Degree in Microbiology or a related scientific field, or an equivalent combination of education and relevant work experience.
- Master’s Degree in Microbiology, Medical Device, Pharmaceutical Sciences, or a related industry field, with hands-on experience in microbiology, sterilization, and microbiological lab practices.
- Minimum 7 years of experience in the medical device, pharmaceutical, or related industry, with a strong history in microbiology, sterilization processes, and microbiological laboratory work.
- Minimum 3 years of experience with a Master’s degree in the same industries and disciplines.
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)