Validation Engineer FTC 18 months

at  Baxter

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.
Baxter Thetford has an opportunity for a 1x Validation Engineers to join our team on an 18-month FTC basis. You will design and perform validation activities associated with new installation projects (CSV / Equipment / Facilities / Utilities / Systems), to the existing manufacturing process and manufacturing of Intravenous products at the Thetford plant. This role is Monday - Friday, 37.5 hours per week based on site in Thetford. Typical hours are 09:00-17:00 but there is flexibility on your start/finish time.
As a Validation Engineer onsite you will be developed into a 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.

You will receive an attractive salary and fantastic company benefits which are listed below.

• 25 days annual leave + bank holidays
• Employee discount scheme
• Blue light card
• Progression opportunities
• Substided canteen
• Westfield healthcare
• Up to 8% pension contribution
• Employee assistance programme

QUALIFICATIONS/EXPERIENCE REQUIRED

• Degree level education in Pharmacy, Chemistry, Biology, Microbiology, Engineering or similar
• Minimum 2 years’ experience and a strong working knowledge of Qualification and Validation (for example, Equipment, Utilities, Facilities, Computer Systems and Cleaning).
• Excellent communication skills
• The ability to work as part of a multifunctional team but also independently

• 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
• Plan and prioritise their workload 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.
• Support and adhere to personnel policies and procedures.
• Provide periodic updates to the Validation Manager.
• Adhere to the Baxter Change Control Management System for all changes to existing or implementation of new systems.
• Perform such other duties as the management may reasonably require from time to time.
• On occasions, be expected to work late and at weekends to ensure time lines are met.
• To work in a safe manner and in compliance with all Baxter Health, Safety & Environment mandatory policies, standards and procedures.