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Qualification Engineer

  • Applications are considered on a rolling basis
  • Beerse +4 more
  • Applications are considered on a rolling basis
  • Beerse +4 more

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.

About the company

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 340,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2021 global revenues of €18 billion.

Get the Future You Want | www.capgemini.com

Manon De Rijcke | Contact Person

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Capgemini Engineering

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