Microbiology Lab Engineer

Terumo Europe NV; Vlaams-Brabant; À distance; USD 85 000 - 125 000; Plein temps

Résumé du poste

Terumo seeks a Lab Engineer Microbiology to develop, validate, implement, and oversee biological testing programs ensuring quality, safety, and regulatory compliance of medical products.

You will lead cross-functional collaborations with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs, drive method improvements, address CAPA findings, and support audits and inspections while upholding a culture of integrity and excellence.

Qualifications

• Master's degree or equivalent experience in a regulated lab environment.
• Proven expertise in microbiological testing, validation, troubleshooting.
• Knowledge of ISO standards, pharmacopoeia requirements, and quality systems.

Responsabilités

• Lead and coordinate 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 testing capabilities by enhancing methodologies, increasing efficiency, optimising laboratory processes, and supporting high service levels across teams
• Coordinate biological endpoint testing with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs to support risk assessments
• Investigate deviations, implement corrective and preventive actions (CAPA), and collaborate with stakeholders for timely resolution
• Serve as SME and point of contact for audits and regulatory inspections, representing the organisation
• Assess and support implementation of new regulatory requirements across manufacturing sites to ensure consistency
• Contribute to cross-functional improvement initiatives, product development, and strategic projects
• Promote quality culture, collaboration, continuous learning, and operational excellence

Connaissances

Biological testing

Microbiology

Data analysis

Regulatory knowledge

Communication

Formation

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

Description du poste

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.

Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for

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 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.

Offer

At Terumo, you will have the opportunity to make a meaningful impact on the quality and safety of healthcare products used by physiciansworldwide. 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

Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.