PROCESS ENGINEER PHARMA (M/V) Beerse
The Senior 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
For this diversified position we are looking for a team player with strong organizational and project management skills who has the ability to focus on complex topics and operates with professionalism.
Key words: validation , process engineer , pharma , GMP, new product introduction
* A minimum of a Bachelor's degree in Engineering and/or a scientific degree or equivalent combination of education and work experience.
* A minimum of 5 years of experience in device and packaging field and/or, manufacturing and/or Research and Development (R&D).
* 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 Flemish and English
You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.
Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, The Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.
For one of our pharma clients in Beerse we are looking for a PROCESS ENGINEER (M/V).
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Engineering / Technics
T 03 203 50 87
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