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Automation MES Engineer - Belgium  

Nalys (company)

Posted on : 04 April 2017

Project Description

About the job Mission: 
  • You will be part of a worldwide project, supervised by a global team.
  •  This team consists of Analysts, Validation Engineers, Technical Engineers and XFP developers.
  •  They drive the system design, development, installation,  validation, support and maintenance. Electronic Batch Management (EBM) is a divisional initiative for deploying a MES (Manufacturing Execution System) solution based on the Siemens XFP software across our client's facilities (Europe, US and Singapore). 
  • To help our client facing the increased number of projects and reinforce standards across facilities, our company is looking for a Global EBM Validation Engineer. 
  • You will lead and coordinate qualification / validation activities linked to your part of the business. 
  • You have the accountability of all validation aspects  and must ensure that systems are properly validated and works as intended. 
  • You will prepare and implement the validation documentation required to assure the proper development of a project and support regulatory submissions.
  • You will act as a validation representative for projects and :
    • Define and implement all validation activities related to the project.
    • Develop the Validation Plans: define validation methodology and approach
    • Provide validation expertise and guidance for the development of the project.
    • Participate in the risk assessment related to the project.
    • Review URS, FS and DS for validation requirements.
    • Prepare and implement commissioning, IQ, OQ & PQ protocols.
    • Manage traceability throughout the whole project validation file (from URS to PQ).
    • Organize and coordinate commissioning, IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required)   in such a way that all of them concur with the time frames committed with the project leader.
    • Participate to testing activities, analyze, interpret, document and report the testing results.
    • Ensure the follow-up and tracking of the validation activities. Update the validation documentation system.
  • Assure feedback of status and issues to Quality department head.
  • In collaboration with QA representative, you will manage deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon.
  • You will be involved in the development of expertises in IT technical solutions and also align validation aspects accordingly
  • You will have to coordinate activities of validation engineers and contractors.  

About you 
  • You hold a Master in electronics, electromechanical or mechatronics
  • You have at least 3 years of proven experience in Automation or a similar position in a manufacturing environment
  • You have a good knowledge of :
    • Manufacturing Systems (MES)
    • Manufacturing process, 
    • Validation methodologies (GAMP5, ASTM 2500...)
    • 21CFR part 11 and global European & FDA regulations as well as GMPs.
  • You are fluent in French with a good level of English
  • Corporate values mean a lot for us. We expect them to mean something for you  

About us 
  • Our company is a people company. 
  • We will give you the opportunity to challenge yourself while doing something you love.
  •  So whether you are a creative, a dreamer or an achiever, you can find a way to do something you truly enjoy.
  •  And because we want our company values to be more than words, we invest 7% of our annual revenue to drive innovation, develop your expertise, train your brains and give you time & tools to think big.

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