Senior Process Validation Engineer

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

We are actively searching for a Senior Process Validation Engineer to join our team of wonderful people based in our Castlebar, Co. Mayo site. The Castlebar and Swinford facilities employ more than 1300 staff and we operate 24/7.

You will play a key role in the Quality and Process within our manufacturing, support equipment and processes which are critical to saving and sustaining lives.

Working in the Process Validation Department the successful candidate will be self-driven and motivated person willing to learn and further develop their career as a Senior Process Validation Engineer. The successful candidate will be coached/mentored, and Senior process validation training will be provided.

What will you do?

• Author validation protocols, reports and risk assessments
• Leading a team of process validation engineers though Process/Equipment changes
• Review engineering trials and product development documentation
• Complete Trackwise 8 validation and risk assessments
• Technical approval of validation documentation
• Lead projects to ensure they are executed in a controlled and compliant manner
• Provide status updates on projects
• Presentations and project management

Education and Requirements:

• You will have a degree in Science/ Engineering or equivalent
• Process validation experience is desirable
• Knowledge of EU GMP and FDA regulatory requirements
• You will have critical thinking and problem-solving skills
• Ability to demonstrate solid decision making and problem-solving abilities.
• Membership of a professional body desirable

*Absence of more than 20 days in the last year (prorated for hours worked) will disqualify you from the recruitment process.

Applications must come through Workday and must include a CV.

Should you have any issues with your application please contact Talent Acquisition

Joshua_brown_bolton@baxter.com

Closing Date: 10th Oct 2024

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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