LanceSoft, Inc.
Job Title: Sterilization Microbiologist
Location: Plymouth, MN 55442
Duration: 12 Months
8 AM to 4:30 PM
Description :
Job Responsibilities:
- Perform sterilization validation for new and existing products utilizing Ethylene Oxide and/or Radiation sterilization which may include comparative resistance studies and/or EO/ECH residual testing.
- Support R&D for sterilization validation of new products and changes to existing products.
- Provide product development teams sterilization Subject Matter Expert support
- Support Supplier Change Notifications by evaluating impact of change to product bioburden, bacterial endotoxin, and sterilization
- Support changes to the manufacturing environment by writing Environmental Disturbance Reports (EDR)
- Conduct investigations as needed related to environmental monitoring, compressed air, bioburden, bacterial endotoxin, or sterilization
- Plan and organize project assignments of substantial variety and complexity.
- Initiate or maintain schedule for projects and project milestones. Establish priorities of individual or project assignments.
- Selects methods and techniques to lead a project to completion.
Qualifications :
- Bachelor's degree in a related scientific field plus 5+ years of related work experience with a complete understanding of specified functional areas, or an equivalent combination of education and work experience.
- Comprehensive knowledge of medical device manufacturing and sterilization.
- In-depth knowledge of business unit functions and cross group dependencies/ relationships.