PROCESS ENGINEER

BeerseIFarmaceutische industrie

Functieomschrijving

We are looking for a PROCESS ENGINEER for NEW PRODUCT INTRODUCTION for our pharmaceutical client in Beerse. 
The primary focus of this group is to provide technical competence and manufacturing excellence to the pharmaceutical environment and productportfolio. 

Position Description 
The PROCESS ENGINEER will support the implementation of a new combination product and will be responsible for design transfer activities including qualification of manufacturing equipment and process validation. This position will also be in a close collaboration with the Packaging COE and Packaging Development organization for successful introduction and qualification of the new packaging components and corresponding packaging process. 
Your key responsibilities will include 

  • Process development for device assembly and packaging. 
  • Commercialization activities including process and equipment qualification (IQ/OQ/PQ), 
  • Verification and validation of test process and test fixtures to meet targeted test coverage and effectiveness. 
  • Preparation and oversight of packaging development activities including preparation and organization of transportation studies
  • Collection and analysis of test data to identify problems, optimize processes and drive continuous process improvements including feedback to suppliers, manufacturing and development engineering
  • Collection of design transfer documentation for consideration within the Design History File 
  • Collaborating with site operations, supporting any improvements to the processes and/or equipment, to ensure reliability at the highest possible levels
Profiel
  • You have a Bachelor’s or Master's degree in Engineering and/or a scientific degree or equivalent combination of education and work experience. 
  • You have a minimum of 5 years of experience in device and packaging field and/or, manufacturing and/or Research and Development (R&D). 
  • You have broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing marketed products is required. 
  • Experience with FDA regulated Design Control, Change Control and ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purpose, European Medical Device Directive is required. 
  • Fluent in both Dutch and English 
Organisatie- en afdelingomschrijving

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.
 

Aanbod

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Heb je nog vragen?
Bénédicte Joret Business Unit Manager Life Sciences Select Projects +32 3 203 50 88
PROCESS ENGINEER Vacature informatie
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