Validation Engineer

Department Info

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.

Job Summary

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.

Job Responsibilities

• 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

Profile Description

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 processes

• Proficiency in MS Office; experience with SAP is a plus

• Fluency in English and Dutch; English for reporting and documentation, Dutch for Tier meetings and everyday communication

Offer

• Make a meaningful impact: Be part of a company that contributes to society through healthcare. At Terumo, your work contributes to the production of innovative medical devices that improve patient outcomes and support healthcare professionals in delivering safer, more effective care. 
• Rewarding your impact: Enjoy a comprehensive salary package including medical insurance, pension plan, net allowance, iPhone, meal vouchers, full public transport reimbursement, and the option to lease an (e-)bike, along with a competitive gross salary aligned with market data.
• A team that cares: Join a passionate and high-performing team where respect, diversity and inclusion are at the heart of everything we do. We value collaboration and encourage every voice to be heard.
• Invest in your development: We provide a wide range of development opportunities to help you grow personally and professionally. 
• Connect with us: During the recruitment process, you will have the opportunity to engage in meaningful conversations with the hiring manager and other Terumo associates. 

Contact Person

Marjolein Buyl 

Talent Acquisition Business Partner