Validation Engineer, Compounding

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.
Thetford Compounding is currently seeking a Validation Engineer to join our team. Our company is dedicated to upholding a seamless validation process for our manufacturing facility, equipment, processes, and systems. As a Validation Engineer, you will have a vital role in ensuring our site adheres to Good Manufacturing Practices (GMP) and regulatory standards.
You will have the opportunity to work with a team of 5 who share your passion for excellence. Additionally, you will collaborate closely with a diverse team, allowing you to gain exposure to various areas of our organisation. This unique aspect of the role offers exceptional prospects for career progression within our world-class company.

WHAT EXPERIENCE ARE WE LOOKING FOR?

• You will have a Scientific/Engineering Degree or equivalent qualification.
• You will be able to demonstrate working knowledge of validation in a pharmaceutical/FMCG/medical devices environment preferably.
• Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems would be preferred.
• Approach tasks with a logical and practical perspective, and have a proactive approach to problem-solving.
• Display analytical thinking and innovative problem-solving abilities to successfully implement validation strategies.
• Self-motivated and driven to complete projects/tasks efficiently and effectively.
• Excellent teamwork skills to contribute effectively as a member of a diverse team and effectively communicate with individuals involved in the project.

• Ensure Site Validation Master Plan (SVMP) is strictly adhered to and that all validation activities are conducted in accordance with established protocols and procedures.
• Develop and implement validation documents and protocols for a variety of processes, equipment, facilities, and systems, with a particular emphasis on aseptic manufacturing.
• Work closely with teams from various departments to assist with the implementation of new processes, products, and equipment at the site. This involves developing detailed documentation, including Validation Plans (VP), User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Actively participate in the assessment, review, and approval of changes that may impact the validation status of our facilities, equipment, processes, and systems. This involves ensuring the correct operation of our change control process.
• Conduct thorough reviews of validation execution and equipment changes carried out by external contractors and internal project team members to ensure compliance with validation requirements.
• Take ownership of project management and execution for Capital Expenditure and Process Improvement Projects within the EMEA Validation project portfolio.