Process Validation Engineer

3 weeks ago


Galway, Galway, Ireland Vantive Full time

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

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 is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

CV must be attached to your application

Process Validation Engineer

We are actively searching for a 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 extending lives and expanding possibilities.

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 Process Validation Engineer. The successful candidate will be coached/mentored, and process validation training will be provided.

What will you do?

  • Author validation protocols, reports and risk assessments
  • 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

Your Qualities
  • 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.
  • You will work well within a team environment

What Can Vantive Offer To You
  • 25 days Annual Leave with a possible addition of 4 days per year
  • Competitive Salary
  • Extensive benefits package
  • Sports & Social activities

Reasonable Accommodation

Vantive 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. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive 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.
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