Under the direction of R&D Research Manager, the Sterility Assurance Technician will be responsible for acting as a core team member in projects involving radiation (gamma and e-beam) and ethylene oxide sterilization of commercial laboratory consumables, including medical devices.
- You will report to R&D and support Manufacturing Operations / Supply Chain as needed.
- Works closely with Sterility Assurance Leaders and assist them in developing and executing our sterilization strategy.
- Work closely with sterilization suppliers, technicians, engineering, project managers, product managers, and packaging engineers to ensure that the product specific sterilization processes are properly validated and documented.
- This role will need to have effective time management and multi-tasking skills and have a team player mindset.
- Support the Sterility Assurance subject matter experts with: New product introductions; New supplier qualifications; Test plans for product and/or process changes affecting sterile products.
- Execute sterility and shelf-life validation documentation such as protocols and reports
- Work closely with contract sterilization providers for routine sterilization process development
- Assist with the review quarterly dose audits and annual re-validations.
- Support customer, notified body, and regulatory audits as needed.
- Minimum Bachelor’s degree
- Minimum 2 years related sterilization experience, must include ebeam.
- Experience in regulated environment (cGMPs, ISO 13485, ISO 9001, etc.)
- Experience with sterilization of medical devices
- Familiarity with ISO, AAMI, ASTM standards relating to sterilization and related topics