Qualification Engineer

☞ Capgemini

看过: 120

更新日: 26-11-2025

位置: Ghent East Flanders

类别: IT-软件 IT-硬件/网络 信息技术

行业:

工作类型: Full-time

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工作内容

Your role

As a Qualification Engineer your role consists of qualifying equipment from replacements to introductions of new equipment materials. You are active in multidisciplainary project teams, which results in a combination of autonomous tasks and teamwork engagements with colleagues of all sorts of departments. It is your mission to be and become a specialist in all Qualification activities.

  • You create and execute Qualification protocols, and report on the progress being made.
  • You make sure GMP standards are being implemented and make sure they are translated in Qualification activities.
  • You follow-up on all activities concerning the protocols, document the results, quality incidents and deviations.
  • You define the cause, effect and actions and make sure the preventive measures are documented and managed.
  • You present and defend the approach of the Qualification actions towards internal stakeholders.
  • You participate in Continuous Improvement projects.
  • You write operational procedures.
  • You are active in this role in the region of Antwerp (Puurs, Geel, Beerse) and have contact with numerous contacts in diverse department throughout the complete organization.

Your profile

  • You have a Master degree in a Technical domain or equal by experience.
  • You are familiar with GMP/GDP and have relevant experience with Qualification activities (writing URS, DQ, IQ, OQ, PQ protocols and reports, with testing and documentation, risk analysis, experience with P&ID’s, etc.)
  • You have prior experience in a GMP environment, preferably Pharma, Biotech and/or Medical Devices.
  • Knowledge about safety documentation for Change Control would be an extra.
  • You write and speak fluent Dutch and English.
  • You have strong administrative skills, pragmatic, able to work both autonomously and in team, critical and focused on solutions.
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最后期限: 10-01-2026

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