Validation Engineer

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.

Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for.

At our Leuven plant in Belgium, Terumo Europe produces around 800 million injection needles, solutions and related accessories each year. These products are developed in close collaboration with our pharmaceutical customers to meet their specific medical and patient needs. Our flexible, highly automated production lines earned a Factory of the Future award, reflecting both advanced technology and a people-focused approach.

Our team of three validation engineers plays a critical role in ensuring these processes are robust, capable, and fully compliant. They validate new and existing production lines, analyze process performance, identify improvements, and ensure that quality standards are consistently met. Working across multiple lines and machines, the team collaborates closely with Engineering, Operations, and Quality to maintain high-quality, efficient, and innovative manufacturing.

As Validation Engineer
, you take ownership of ensuring the robustness, capability, and quality of our production processes. You coordinate and execute validation activities,including IQ/OQ/PQ testing, risk assessments, and documentation,while analyzing performance and implementing process improvements.

This role offers a hands‑on, impactful opportunity to combine technical insight, analytical thinking, and a quality mindset in a dynamic, innovative production environment.

Validate, analyze, and evaluate existing product lines and processes after a thorough training period

Prepare and execute IQ/OQ/PQ validations for both new processes and machines, as well as routine validations

Lead impact and change assessments, determining what needs to be validated and its effect on the process

Perform risk analyses (including PFMEAs), monitor process changes, and follow up with process engineers to ensure validation requirements remain up to date

Organize, execute, and document validation tests, including sampling, data collection, statistical analysis, and reporting

Develop, maintain, and monitor the Validation Master Plan (VMP) and ensure validation documentation meets internal and regulatory standards

Map failures within processes or protocols and provide advice on improvements to enhance process stability and quality

Review process performance, identify recurring issues, and determine whether additional validation activities (e.g., COCs) are required

Act as a validation specialist and point of contact during internal and external audits, providing expert input on all validation topics

Whether you are a motivated young graduate or an engineer with experience in production or process environments, we value above all an analytically strong, technically minded professional who thrives in a dynamic setting where quality, data, and process understanding come together. You have a genuine interest in working in a production environment where quality is paramount and where your curiosity, precision, and drive for improvement can truly make an impact.

What do you bring to our team?

A Master’s degree in Engineering or equivalent

Strong analytical skills, statistical knowledge, and experience with data analysis (e.g., Minitab)

Comfort with handling documentation and administrative tasks, including writing clear and accurate technical reports

The ability to build strong working relationships with diverse internal stakeholders (e.g., Engineering, Operations, Quality)

The capacity to apply requirements and regulations thoughtfully while staying pragmatic, solution‑oriented, and focused on what really matters for product quality

The ability to work autonomously, take responsibility, and proactively drive tasks forward

A critical mindset, continuously looking for ways to improve validation…