Product Support Engineer
Pfizer Inc. is a research-based company, known as the number one global biopharmaceutical giant. They apply science and global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacturing of healthcare products. The global portfolio includes medicines and vaccines, as well as many of the world’s best-known consumer healthcare products.
In this role as project support engineer you will report to the Lead Engineer Components & Devices. The project engineer is responsible for running projects in the department Product Support within the Packaging & Delivery Systems team. You work in close cooperation with internal departments like production, QA, procurement, R&D en HQ teams as well as with external suppliers is required.
Main tasks and responsibilities:
• You are responsible for the execution of projects in the department Product Support within the Packaging & Delivery Systems team.
• You are an expert in the domain of Medical Devices and Combination Products.
• You coordinate the entire process, from introduction of new components to improvement projects of existing components.
• You generate or evaluate new ideas, execute feasibility studies and risk assessment (tolerance analysis, FMEA, …), execute tests and conduct eventual implementation in production.
• You are able to define the critical quality attributes of the components thanks to your process knowledge.
• You secure product quality and patient safety thanks to your knowledge of the characteristics of the materials.
• You are able translate the requirements into technical specifications.
• You develop or select correct measuring methods for control (sample plans, test plans, Gage R&R studies).
• You act as an expert by continuously staying up to date about your knowledge of the domain, feedback from the market and staying on top of the production issues.
• You analyze the gathered information and use the necessary tools (6 Sigma Green/Black Belt, DMAIC, …) to make improvements.
• You troubleshoot and work in close corporation with the suppliers and production to implement the appropriate actions.
• You are responsible to be compliant with the legislation.
• You define and optimize of packaging systems with an audit ready and compliant packaging system in mind.
• You have a Master’s degree in a scientific field.
• You have a minimum of 3 years of experience in a medical device packaging environment.
• Experience within a quality department and/or production department in combination with packaging expertise is a strong plus.
• You are fluent in Dutch and English.
• Knowledge and experience of DMAIC or 6 Sigma is a plus.
• You have thorough understanding of regulations and legislations of medical devices or combination products.
• You possess excellent social skills, are a team player and show coaching skills.
• You are passionate about technical aspects and work to achieve 100% accuracy.
• You are a strong troubleshooter.
• You have a deep knowledge of statistics and have strong analytical skills.
• You possess a problem solving hands-on mindset.