Qualification & Validation Engineer M/W/X

☞ AMARIS CONSULTING BELGIUM

看过: 170

更新日: 16-11-2025

位置: Woluwe-Saint-Lambert Brussels Capital

类别: 生产/工艺

行业:

工作类型: Voltijds

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工作内容

Company description

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses.
With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade ¿ this is made possible by an international team of 6000 people spread across 5 continents and more than 60 countries.
Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering.
We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential.
Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.


Description of the function

INTRODUCTION & CONTEXT

As a Qualification & Validation Consultant, you will have the chance to work in a multi-national environment and develop your expertise by working on diverse projects.

ROLES & RESPONSIBILITIES

Reporting to the project leader and working in close collaboration with a team of Qualification and Validation experts, you will have the following responsibilities:

  • Create user requirements (URS)
  • Define the validation strategy based upon the clients’ guidance and benchmarks
  • Build validation and qualification plans
  • Coordinate and perform FAT/SAT as well as equipment commissioning
  • Execute tests (IQ/OQ/PQ/DQ)
  • Coordinate and review the related GMP documentation needed for change control
  • Ensure the planning of validation and qualification strategies in accordance with all the concerned parties (production/QA/maintenance)
  • Ensure the operational management of the technicians dedicated to the validation
  • Maintain equipment to support GMP manufacturing
  • Foster innovation and continuous improvement on process, and on qualification and validation projects

Profile description

THE IDEAL PROFILE

  • You hold at least a master’s degree in engineering, bioengineering, biology, pharmacy or related fields.
  • You hold at least one year of experience in qualification / validation in GMP environment.
  • You are familiar with the processes and legal requirements for pharmaceutical industry.
  • You have technical understanding of manufacturing equipment (autoclaves, washing machines...) and processes specific to Pharmaceutical manufacturing preferred.
  • You are familiar with creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ).
  • You are proactive, have good communication skills, and can work in a multidisciplinary team towards a common goal.
  • You are proficient in French and English. Dutch is a plus

Additional information
Workplace ,
Contract type : CDI
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最后期限: 31-12-2025

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