Sterilization Engineer

Department Info

Terumo is a manufacturer of medical devices. In Leuven, Terumo produces approximately 800 million injection needles, injection solutions, catheters and necessary accessories per year. On the one hand we develop and produce products for hospitals, on the other hand we produce specifically developed products according to the needs, questions and medicines of our pharmaceutical customers. To make this far-reaching personalization possible, investments were made in a flexible machine park with a high degree of automation. We were very proud to recently achieve the title of Factory of the Future, which testifies to progressive production technology and a people-oriented organization.

Department information

Terumo EMEA Quality, operating from Leuven (Haasrode), Belgium, provides supporting services in quality systems, quality assurance and quality control to Terumo internal and external customers.

Job Summary

Development, implementation, supervision and coordination of all monitoring and process/product (re)qualification activities (IQ/OQ/PQ) related to (changes of) sterilization to assure product sterility in accordance with the applicable standards.

Daily monitoring of the sterilization process of products manufactured in Terumo Europe.

Job Responsibilities

• Develop sterilisation cycles for new product introductions and take ownership of the introduction in the plant - from equipment selection to executing qualification activities in-house or in collaboration with a sub-contractor. Once implemented, guard compliance and efficiency of the process. All these activities to be executed in close collaboration with Product Engineering to ensure all product requirements are met. 
• Organize, perform and coordinate (re)validation activities of the sterilizers (both in- and at the sub-contractor) as well as any other critical equipment in line with company procedures and international standards.
• Daily monitor the sterilization process (both in- and at the sub-contractor) (incl. review of sterilization results and release) and coordinate the implementation of countermeasures and actions in case of deviating process results. 
• Monitor the need for upgrading sterilization cycles in accordance with increasing market demand (e.g. development of new products) and keeping cycle efficiency (throughput) high at lowest cost.
• Monitor and evaluate regulatory standards for changes to ensure that the sterilization processes implemented in Terumo Europe remain compliant with the applicable standards and are translated as such in internal procedures.
• Evaluate potential sterilization impact and define required actions in case of changes (e.g. new product introductions, design and packaging configuration changes, modifications to sterilization process and equipment, …)
• Act as spokesperson for the sterilization process during customer audits & regulatory inspections (Notified Body, FDA, …).
• Be the first point of contact for questions regarding the sterilization process for Terumo associates and the sub-contractor.  Provide training to sterilization operators and other stakeholders when needed.
• Prepare and host the Quality Review Meeting with the sub-contractor and follow up on the open actions. 
• Support internal audits at the sub-contractor as sterilization expert.

Profile Description

• Master’s degree in (Bio)Engineering, biology and/or microbiology or equivalent by experience
• Detailed knowledge of sterilization processes (ETO, moist heat and irradiation), validation approaches and the related equipment
• Knowledge of the European and ISO standards related to Sterilization (EN ISO 11135; EN 285; ISO 17665; EN ISO 11138)
• Ability to work well in a team environment and foster cross-functional collaboration
• Self-starter and committed to adhering to deadlines
• Strong analytical skills
• Strong problem-solving skills
• Knowledge of statistical techniques
• Quality mindset and attention to detail

Offer

Contact Person

Peter Coolen

Talent Acquisition Partner