Advanced Validation Engineer

Department Info

Terumo is a manufacturer of medical devices. In Leuven (Haasrode), Terumo produces about 800 million hypodermic needles and injection solutions per year.

Within this Pharmaceutical Solutions department, we produce specifically developed products according to the needs, questions and medicines of our pharmaceutical customers. To make this far-reaching personalisation possible, investments were made in flexible machinery with a high degree of automation. We were proud to recently achieve the title of Factory of the Future, which testifies to a progressive production technology and a people-oriented organization.

In the run-up to the start-up of the new Pen Needle Organization (planned for early 2027), we will work in project mode, which means that you will have flexibility in tasks and responsibilities. After all, as an organization we will gather knowledge on the basis of practical experience (which we gain during machine construction, making all machines and systems ready for production and the various validation phases) and will also have to log and train it while the organization is gradually expanded.

To support this as much as possible, we are looking for candidates who:

• Be open to change and willing to learn new skills.

• Be flexible and be able to adapt easily to different situations, even without having the full picture.

• Be proactive in tackling new challenges and finding solutions, even when the solution is not immediately clear.

• Efficient collaboration in a dynamic and changing environment.

If you are someone who wants to learn, can adapt quickly, and acts constructively, we would like to invite you to apply!

Job Summary

As our Validation Engineer you evaluate and challenge the design concept through criticality assessment and translate this into clear input for test approach and the plan for further validation. You ensure Terumo Europe's compliancy and high standards by setting up internal standards & processes and guiding the organization to this result. 

Job Responsibilities

1. Execution of validation activities on new and existing production lines by control of mitigations of processes in line with the reliability of the processes on short and long term, based on risk impact by means of pFMEA
2. Understand the concepts of validation within the concerned domain of validation, keep this knowledge up to date and defends the principles both inside as outside Terumo-Europe, either or not in frame of an audit.
3. Defend the concepts and principles of the validation practices int the concerned domain and the translation into described rules, procedures and themes towards the whole process validation team by coaching and training
4. Control the concepts and principles of validation within the concerned domain by means of reviewing, consulting and advising and or auditing. Attends the validation engineers on their responsibility and continuously follow-up the corresponding goals by means of meetings, assessments and/or other control tools.
5. Improve and inforce the validation practices both as concepts as in the production teams in order to provide the best manufacturing ROI on short and long term
6. Participates in projects to control validation activities while keeping cost and schedule within total project budget and schedule. Or acts as leader for appointed delegates (internal resources, consultants or external engineering offices in the built network).

Profile Description

• You have a Master's degree in engineering or equivalent 
• Work experience in the related competence field in a comparable function where you dealt with different processes like assembly, molding, utilities, …
•  Knowledge of MS office word/excel, SAP is a plus
• You're fluent in English and Dutch (or have the willingness to improve basic Dutch) 
• Experience in data analysis (knowledge of Minitab is a plus) 
• A team player with strong communication skills is essential because of the contact with various stakeholders
• Must be able to work autonomously and take initiatives
• Customer focus is crucial to be able to translate a technical report into a clear overview for the customer
• A critical mindset (with the aim of continuously improving the current validation processes)

Offer

Working for Terumo means contributing to society through healthcare.

Terumo offers an attractive salary and benefits package. Besides meal vouchers, interesting insurances, 100% public transport reimbursement, you also have the possibility to lease an (e-)bike.

We offer an opportunity to work in a top performing team. An organisation where everyone is treated with respect. We strive to create a diverse, equal and inclusive work environment. We invest in our associates by offering a broad array of development opportunities.

Linked with our core value Care, Terumo allows a hybrid way of working, combining office with home-based work. For the this role you can sometime work from home, however due to the tasks, you'll spend most of the time in the office. During your recruitment process, you’ll be able to have conversations with Alex Diepvens as the hiring manager and other passionate Terumo associates.

Contact Person

Peter Coolen

Talent Aquisition Partner