Sterilization Process Engineer

Found in: Talent US C2 - 1 week ago

Buffalo Grove, United States Abbott Full time

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As a Sterilization Process Engineer, you will perform sterilization validation for new and existing products utilizing Radiation sterilization methods. Supports R&D and manufacturing for sterilization validation of new products and changes to existing products. This is an onsite opportunity in Austin, TX or Buffalo Grove, IL.

What You'll Do

Performs sterilization validation for radiation sterilized products including dose setting, quarterly dose audits and equipment qualification. Provides sterilization subject matter expert support to development and Quality teams, as well as Third Party Manufacturers. Support Microbiological activities across development and Quality teams, as well as Third Party Manufacturers.  Assist in Supplier Quality audits of contract sterilization facilities and third-party manufacturers. Responsible for sterilization non-conformance investigations in conjunction with associated third parties. Incorporates business policies and procedures into task completion. Understands the business needs of the company and has knowledge of the customer needs of our business. Understands the business cycle and foresight of emerging technologies trends. Ability to travel 70% first year.

EXPERIENCE YOU’LL BRING

Required:

Bachelors’ degree plus related work experience with an understanding of specified functional area, or an equivalent combination of education and work experience.  Preferred knowledge of a Radiation or other sterilization modality. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Exercises authority and judgment within defined limits to determine appropriate action. Ability to work alone or as part of a team to achieve results.

Preferred:

Must have 3-4 years of Sterilization experience.  Experience or awareness of Cleanrooms & microbiological monitoring Knowledge or awareness of relevant ISO Standards – e.g. ISO11137

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