Validation Engineer

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.

Summary

We are currently recruiting a Validation Engineer at our high performing API manufacturing plant in Wavertree Liverpool.

The Validation engineer is responsible for: elements at the Liverpool Manufacturing Site.

This position will work closely with the QA, Laboratory and Engineering and Production teams

to assure validation is are effectively completed and maintained to ensure compliance with

Regulatory and Baxter Corporate requirements. The Validation Engineer will report to the Validation Manager.

Working hours are Monday to Friday, 9am until 5pm (with some flexibility)

Key Responsibilities

Writing validation protocols associated with equipment, analytical methods and CSV

Working with engineering projects to scope out the validation requirements of new

projects.

SME for Computer systems integrity

Act as a coach for validation activities.

Partaking in the site processes for:

Global Observation Certifications

Internal Audit program

Investigations inc. NCR and CAPA

Implement leading validation indicators and continuous improvement of the validation

process.

Undertake the following quality system roles (including access to the relevant system):

NCR/CAPA: trainer, Initiator, owner

Change control: Owner

Document: owner

Qualifications and/or Experience

Knowledge and application of validation techniques, including computer systems.

Applies analytical skills and knowledge of data analysis tools and methodologies.

Cross functional collaboration.

Working within set deadlines for projects and to required regulatory standards.

What are some of the benefits of working at Baxter?

• Competitive total compensation package

• Professional development opportunities

• High importance placed on work life balance

• Commitment to growing and developing an inclusive and diverse workforce

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

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