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Validation Engineer (12 month FTC)

Req #: JR - 037538 Location Thetford, England, United Kingdom Job Category: Quality Control Date Posted: 04/01/2021

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.

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  • Paid Time Off

  • 2 Days a Year to Volunteer

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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
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Validation Engineer (12 month FTC)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

Baxter Thetford has an opportunity for a two Validation Engineers to join our team on 12 month Fixed Term contracts. You will design and perform validation activities associated with new installation projects (Equipment / Facilities / Utilities / Systems), to the existing manufacturing process and manufacturing of Intravenous products at the Thetford plant.

As a Validation Engineer onsite you will be developed into the primary contact and validation subject matter expert, responsible for authoring, executing and reporting validation activities within the framework. You will manage multiple validation projects, liaising with the project team and various departments relating to the validation ensuring work is completed in a timely manner.

You will be trained on the of Validation requirements for Equipment / Facilities / Utilities including associated control systems. In addition, you will gain the working knowledge in EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and associated computerised system validation within the pharmaceutical environment.

Essential Duties and Responsibilities

  • Lead validation activities on specific projects including defining the validation requirements to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP

  • Ability to translate local, corporate and regulatory requirements into validation requirements

  • Liaise with project team members

  • Ability to perform Risk Assessments, such as Failure Mode Effect Analysis (FMEA) for example, to critique a process or equipment and thereby define the level and scope of validation required

  • Ability to write User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation and / or trial purposes

  • Run validation project execution DQ/IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved

  • Proactively coordinate validation activities and act as a central point of contact for the project team for validation to ensure the projects are delivered on schedule

  • Be involved in the Implementation of a risk based approach to the validation of systems including computerised systems residing in Thetford. Initial system risk assessments are to be completed to determine scope and extent of necessary validation activities as well as temporary risk mitigation controls.

  • Author and report validation documentation to meet regulatory and Baxter standards

  • Resolve both GMP and business issues and deviations

  • Plan and prioritise their work load to ensure that agreed deadlines are met.  This includes coordinating and performing validation activities, tracking and reporting the progress of activities, anticipating and removing obstacles to progress

  • Provide periodic updates to the Validation Supervisor, Process QA Manager and Quality Assurance Leaders

  • Adhere to the Baxter Change Control Management System for all changes to existing or

Qualifications

  • Experience within pharmaceutical or medical devices ideal but not essential

  • Minimum: degree level education in Pharmacy, Chemistry, Microbiology, Engineering or similar or equivalent industry experience.

  • Experience in Equipment / Process systems, Cleaning Validation, HVAC, QA, QC or Cleanroom systems would be preferred

#IND-UKOPS

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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."

Christelle

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."

Lorena

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."

Gary

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.

Christelle

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."

Lorena

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."

Gary

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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