Validation Engineer

☞ Akkodis

看过: 135

更新日: 03-11-2025

位置: Geel Antwerp

类别: 高科技 咨询/客户服务 生产/工艺

行业: IT Services IT Consulting Medical Practices Medical Equipment Manufacturing

水平: Associate

工作类型: Full-time

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工作内容

Company information:

Akkodis is a global digital engineering company and Smart Industry leader. We enable clients to advance in their digital transformation with Talent, Academy, Consulting, and Solutions services. Our 50,000 experts combine best-in-class technologies, R&D, and deep sector know-how for purposeful innovation. We are passionate about Engineering a Smarter Future Together.

Within Akkodis we are looking for a validation engineer for one of our clients in the region of Beerse. Our client is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases.

Description: Validation Engineer

  • Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
  • Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems.
  • Responsible for the validation documentation through approval and implementation.
  • Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and the companies Procedures.
  • Ensures that the Validated Status of computerized systems is in compliance with cGMP at all times.
  • Ensures projects (moderate scale & complexity) are managed in conjunction with all the cGMP regulatory standards.
  • Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements.
  • Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
  • Investigates/troubleshoots moderately complex validation problems.
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最后期限: 18-12-2025

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