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Process Engineer

BE1887

DPS Group Belgium is looking for a Process Engineer for a pharma project in Beerse.

Category:
Engineer Process / Food / Dairy Science
Location:
Belgium
Years of Experience Req.:
4-6 years
Date Posted:
30/07/2020
Days Remaining:
19
Employment Type:
Contract
Education Level Req.:
University/Bachelors Degree or Equivalent
Introduction
Our pharmaceutical client is recruiting for a Senior Engineer for New Product Introduction. 
This position is based in Beerse and resides in the Device & Packaging COE, a department within the Technical Operations (TO) division. The primary focus of this group is to provide technical competence and manufacturing excellence.

Position Description
The Senior Engineer will support the implementation of one or more new combination products like co-packed kits, auto-injectors, syringe kits, … The senior engineer will be responsible for design transfer activities execution and documentation, including qualification of manufacturing equipment and process validation.

The Senior Engineer will collaborate closely with other NPI, engineering and Subject Matter Expert (SME) functions in the D&P CoE, the Beerse site and the Primary Container and Device Development (PC&D) organiz780774.92146ation for successful introduction and qualification of the new device and packaging components and corresponding assembly and packaging processes in the commercial supply chain.

For this diversified position we are looking for a team player with strong organiz780774.92146ational and project skills. A good candidate is capable of navigation through complex topics, has the professionalism to communicate in a correct and timely manner and continuously demonstrates a strong mindset to deliver on deadlines.
Key responsibilities
- Process development for device assembly and packaging.
- Commercializ780774.92146ation 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 organiz780774.92146ation of transportation studies.
- Collection and analysis of test data to identify problems, optimiz780774.92146e 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

Hard Skills
- A minimum of a Master degree in Engineering and/or a scientific degree or equivalent combination of education and work experience.
- 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.
- A minimum of 5 years of experience in combination products or medical device manufacturing, assembly, packaging and/or Research & Development (R&D).
- Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing marketed products is required.
- Fluent in both Flemish and English

 

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