Stay up-to-date on Baxter careers

Apply Now    

Validation Manager

Req #: 180003Q0_en
Location: Thetford, ENG UK
Job Category: Quality
Date Posted: 2/26/2018 7:39:13 AM
Baxter International


About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
The Role of the Validation Manager is to manage a team of specialists that lead the design and perform validation activities on new products and process being installed.
Role Responsibilities
  • Ability to translate local, corporate and regulatory requirements into validation requirements
  • Ability to perform Risk Assessments, such as Failure Mode Effect Analysis (FMEA)
  • 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.
  • The management of the computerised Systems Inventory and associated activities
  • To have a breadth of validation and GMP knowledge to allow adaptability to the different types of validation to be conducted including Computer Systems Validation
  • Train staff in validation procedures and principles during execution activities
  • External Contacts – Liaise with suppliers and vendors inputting to the validation of projects being handled


Skills and Experience
  • A Technical/Science degree or equivalent and come from a pharma background (or possibly food)
  • You must have a minimum 3 year validation experience
  • Experience required of working to cGMP and Annex 11 and 15 framework
  • Have a detailed understanding of GMP, quality assurance and documentation systems in a pharmaceutical environment.
  • Be knowledgeable of best practice, and be able to apply them to both actions and documentation related to validation activities.
  • Be proactive in identifying problems and proposing solutions.
  • Be able to write and execute validation plans, protocols and reports.
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, colour, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
Apply Now    
Link for schema