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Process Validation Engineer

Req # JR - 153370 Location Castlebar, Connaught, Ireland Job Category Quality Date posted 11/05/2024
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Process Validation Engineer

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Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our 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 sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Castlebar has a fantastic opportunity for a candidate to join the Process Validations Engineer. This candidate should be looking for an opportunity to stay within the business. This opportunity will be a temporary contract position for 2 years.

Essential Duties and Responsibilities

  • Author validation protocols, reports and risk assessments
  • Review engineering and product development documentation
  • Complete Trackwise 8 validation and risk assessments
  • Critical thinking and problem solving
  • Lead projects to ensure they are executed in a controlled and compliant manner that do not negatively impact batch release
  • Address issues in a timely fashion using critical thinking and problem-solving skills
  • Provide weekly updates on status of all projects, highlighting issues and roadblocks that exist
  • Be able to work both independently and also as part of a team
  • Excellent communication (verbal and written), presentation and project management skills

Qualifications

  • Knowledgeable on EU GMP and FDA regulatory process validation requirements 
  • Understanding of local and corporate process validation requirements 
  • Process validation experience is desirable, however, process validation training will be provided
  • Degree in Science, or equivalent

Benefits

  • Fantastic Salary and Compensation Package
  • Annual Bonus Scheme
  • Paid Medical Insurance
  • Free Life Assurance
  • Subsidised Canteen

Please feel free to reach out to joshua.brown.bolton@vantive.com or alternatively contact laura.mchugh@vantive.com at any time to discuss this role.

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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

153370
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Address

Explore this location Moneen Road
Castlebar
Co. Mayo
Ireland Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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