Microbiology Lab Engineer

Terumo Europe; Vlaams-Brabant; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Terumo Europe is seeking a Lab Engineer Microbiology to lead development, validation, and implementation of microbiological test methods ensuring quality, safety, and regulatory compliance for medical devices. You will work with cross-functional teams to maintain testing programs and drive continuous improvement in a global healthcare setting.

The role requires strong expertise in microbiology, data analysis, and knowledge of ISO standards, with excellent communication for audits and regulatory

Qualifications

• Master's degree or equivalent experience in biology/microbiology in a regulated environment.
• Strong expertise in biological/microbiological testing, including method development and validation.
• Solid understanding of statistics and data analysis for test performance.
• Knowledge of international regulatory and quality requirements (ISO, pharmacopoeia).
• Broad knowledge of product design, manufacturing processes, and quality systems.

Responsabilités

• Lead development, validation, implementation and lifecycle management of biological/microbiological test methods.
• Improve testing capabilities and optimize laboratory processes and efficiency.
• Coordinate biological endpoint testing with cross-functional teams for regulatory compliance.
• Investigate deviations and implement CAPA for sustainable improvements.
• Act as SME and liaison for audits and regulatory inspections.
• Support regulatory updates and ensure consistent practices across sites.
• Contribute scientific expertise to cross-functional improvement and product development initiatives.
• Promote a culture of quality and collaboration across global healthcare solutions.

Connaissances

Biological testing

Microbiological testing

Method development

Validation

Troubleshooting

Data analysis

Statistical methods

Regulatory awareness

Quality systems

Communication

Formation

Master's degree in Biology, Microbiology, Life Sciences, or related discipline

Description du poste

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 worldwide

Profile 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.

We 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.