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Validation Engineer, QA

Req # JR - 026463 Location Lessines, Wallonia, Belgium Job Category Quality Control Date posted 09/09/2020

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Ensure compliance of computerized systems used in the Sterile Drugs and Plastic departments through the establishment GMP compliant validation.

Essential Duties and Responsibilities

  • Act as a validation representative for projects and periodic evaluation that include computerized system validation :
  • Define the validation methodology and approach for the project.
  • Provide validation expertise and quality assurance guidance for the development of the project: direct involvement in the definition of the process/system specifications.
  • Participate in the risk assessment related to the project.
  • Review URS, FS and DS for validation requirements and all applicable QA requirements. Participate in the determination of process or system controls.
  • Participate as part of the project team in the definition of the user requirements and functional specifications of automated processes
  • Prepare validation documentation in compliance with Baxter and cGMP requirements and assure application of these requirements
  • Prepare and implement FAT, IQ, OQ & PQ Protocols.
  • Assure traceability throughout the whole project validation file (from URS to PQ).
  • Organize and coordinate FAT, IQ, OQ, PQ activities with the different involved departments and in such a way that all of them concur to the timeframes committed with the project leader.
  • Analyze, interpret, document and report the testing results.
  • Collect and approve results of validation activities, assure issuance of reports and allow release of impacted product in accordance to internal procedures
  • Approve tests sheets as QA reviewer.
  • Participate in the writing of specifications and SOP’s related to automated manufacturing processes
  • Maintain the validated state through the change control process: analysis of changes, definition of tests to be performed and approval of results
  • Ensure the follow-up and tracking of the validation’s activities. Update the validation documentation system.
  • Maintain the validated state through the periodic evaluation process
  • Develop procedures in compliance with Corporate and Industry requirements
  • Develop and deliver training to employees
  • Optimize the compliance program by showing expertise and leveraging resources with IS manufacturing and other shared services
  • Benchmark of compliance program, inside and outside the company
  • Develop and manage (re)validation program regarding the computerized systems
  • Participate in the communication of the good validation practices


  • Master in Engineering or Science or equivalent through experience
  • Number of years of experience: minimum 2 years in pharmaceutical industries
  • Field of expertise: Validation of Computerized Systems (GAMP) and automated processes or Validation activities with knowledge in computerized system
  • Knowledge of Pharmaceutical Industry requirements and English and French languages
  • Good knowledge of cGMP
  • Experience in validation
  • Good understanding of industrial processes and industrial control systems
  • Good knowledge of current European and FDA regulations
  • Relevant experience in Validation of Computerized Systems (GAMP)
  • Knowledge of Information and Automated systems
  • Teamwork orientated
  • Good communication skills
  • Good problem solving and critical thinking skills

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 and let us know the nature of your request along with your contact information.

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