BE - Senior Engineer Tech Transfer SME Combination Products

Senior Engineer Tech Transfer SME Combination Products (Subject matter expert)

Introduction

The Janssen Supply Chain organization 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 to JJ's pharmaceutical environment and product portfolio.

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) organization 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 organizational 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.
• 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.

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.