Sterility Assurance Technician

Profile

We are seeking a Sterility Assurance Technician for a very important client.

How will you make an impact?
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.

What will you do?
You will report to R&D and support Manufacturing Operations / Supply Chain as needed. Working closely with Sterility Assurance Leaders you will assist them in developing and executing our sterilization strategy. You will also 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 our Sterility Assurance subject matter experts: 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.
Requirement:
The ideal candidate will possess the following qualifications:

How will you get here?
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
How to Apply:
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