Labo Engineer

Bij Terumo ontwikkelen we levensreddende medische technologieën die een blijvend verschil maken in de samenleving. Wil jij samen met ons bijdragen aan een betere wereld? Hier krijg je de kans om je expertise te verdiepen én trouw te blijven aan je persoonlijke ambities.  Onze Japanse achtergrond vormt de basis van alles wat we doen: we handelen met respect, nemen verantwoordelijkheid en streven voortdurend naar verbetering. Herken jij jezelf in deze waarden? Lees dan snel verder – misschien is dit wel dé kans waar je naar op zoek bent. Department Info   The Terumo EMEA Quality and Regulatory (QR) department, operating from Leuven (BE), provides supporting services related to quality, regulatory and complaints & vigilance to internal and external customers in EMEA.   The Laboratory Engineering Section (LES) team, as part of the QR organisation, establishes the framework to ensure that all quality control (QC) tests are performed in compliance with the applicable standards, regulations and customer expectations, using state-of-the-art methods and equipment.
Job Summary   As Lab Engineer Microbiology you are responsible for the development, implementation, coordination, and oversight of all biological and microbiological testing activities to ensure the quality, safety, and compliance of company products, processes, and services. The role provides scientific and operational leadership in testing programs, supports continuous improvement initiatives, and collaborates closely with cross-functional stakeholders to maintain adherence to applicable regulatory requirements and international quality standards while contributing to a culture of integrity & excellence. Job Responsibilities   Lead and coordinate the development, validation, implementation, and lifecycle management of biological and microbiological test methods, ensuring compliance with internal quality requirements and international standards   Drive continuous improvement of biological and microbiological testing capabilities by enhancing methodologies, increasing efficiency, optimising laboratory processes, and supporting high service levels across Quality Control and Laboratory Engineering Services teams   Partner closely with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs colleagues to coordinate biological endpoint testing and contribute to the biological evaluation and risk assessment of medical devices in accordance with ISO 10993   Investigate deviations, implement effective corrective and preventive actions (CAPA), and collaborate with stakeholders to ensure timely resolution and sustainable improvements   Serve as a trusted Subject Matter Expert and key point of contact for internal and external stakeholders, providing expert guidance and representing the organisation during customer audits and regulatory inspections   Assess and support the implementation of new and updated regulatory requirements, standards, and internal procedures across manufacturing sites, working closely with local teams to ensure consistent and compliant practices   Contribute to cross-functional improvement initiatives, product development activities, and strategic projects by providing scientific expertise and recommendations that support innovation, quality, and business objectives   Promote a culture of quality, collaboration, continuous learning, and operational excellence while supporting the successful delivery of safe and effective healthcare solutions worldwideProfile Description   A Master's degree in Biology, Microbiology, Life Sciences, or a related scientific discipline, or equivalent experience gained through a successful career in a laboratory, quality, or regulated environment   Strong expertise in biological and microbiological testing, including method development, validation, troubleshooting, and the application of modern laboratory technologies and equipment   Solid understanding of statistical principles and data analysis techniques used to evaluate test performance, interpret results, and support data-driven decision-making   Thorough knowledge of microbiological principles and their application within highly regulated industries, ideally within medical devices, pharmaceuticals, biotechnology, or healthcare   Good understanding of international regulatory and quality requirements, including ISO standards, European and United States Pharmacopoeia requirements, and other relevant industry guidelines   Broad knowledge of product design, manufacturing processes, and quality systems, enabling you to assess risks, identify improvement opportunities, and support product lifecycle management   Strong analytical and problem-solving skills, with the ability to translate complex scientific information into practical recommendations and business decisions   Excellent communication and stakeholder management skills, allowing you to collaborate effectively across Quality, Regulatory Affairs, Engineering, Manufacturing, and external partners   A proactive and continuous improvement mindset, with a passion for quality, innovation, compliance, and delivering safe and effective healthcare solutions for patients worldwide   Comfortable working in an international and cross-functional environment, where collaboration, knowledge sharing, and scientific excellence are key to success   Excellent spoken and written English languages skills. Dutch is considerd a strong advantage.    Offer   At Terumo, you will have the opportunity to make a meaningful impact on the quality and safety of healthcare products used by physicians worldwide. You will join a collaborative and international environment that values scientific expertise, innovation, continuous improvement, and professional development. In this key role, you will work with talented colleagues across functions and sites while contributing to solutions that improve lives every day.
Contact Person   Lukas Uytterhaegen
- Senior Talent Acquisition Business Partner EMEAWerken bij Terumo betekent de gezondheidszorg met hart en ziel vooruithelpen. Hier krijg je de ruimte om op jouw manier te groeien, word je geïnspireerd om te creëren en te innoveren, en sta je er nooit alleen voor. Sluit je bij ons aan en help mee aan een gezondere toekomst – voor onze patiënten, de maatschappij en elkaar.