• 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.
   

• 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.

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 - AS Applicable)