Process Validation Engineer

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Process Validation Engineer

Materialise

Leuven, Belgium

What you will do

Step into an international, cross-functional agile team that focuses on CMF product development and the corresponding process characterization, development, and implementation;
Your engineering mindset allows you to build thorough expertise in additive manufacturing, post-processing, and quality inspection technologies, allowing you to become the go-to for process-related topics within the agile team;
Identify, define, and implement new processes or process improvements. Data collected in both validation and operational settings allow you to continuously improve the operational quality and efficiency of our processes;
Maintain existing and create new process validation programs in close collaboration with the product development, biosafety, and R&D teams. Identify, define, and execute new equipment validations. Translate this into operational success by providing the right process documentation (work instructions), operator training, and support;
Set up, execute, and analyze process characterization studies to understand the impact of process parameters on process and product output;
Guarantee compliance with QMS requirements by documenting all phases of the process characterization, implementation, and validation per internal procedures;
As a member of the process engineering team, you will work closely with stakeholders from operational, device development, biosafety, research, quality, and regulatory teams. Through involvement in a variety of activities and projects, we set up a growth trajectory in which you can shape your own future within Materialise.

Your profile

You have a master’s degree in engineering or equivalent through experience;
You have initial experience working on process validation in a professional setting;
You have a strong interest in the medical device industry;
You are quality-oriented and have an eye for detail, but you also don’t get stuck on this;
You have a strong, versatile, and proactive work ethic, and you’re eager to learn;
You are good at troubleshooting and problem-solving;
Strong English verbal and written skills required.

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