Microbiology Lab Engineer — Quality & Innovation

Terumo Europe NV; Belgique; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Terumo Europe NV, Leuven-based QR department, seeks a Lab Engineer Microbiology responsible for developing, implementing, coordinating and overseeing biological and microbiological testing to ensure product quality, safety and regulatory compliance across global operations.

You will lead test method development and validation, drive improvements, collaborate with Product Engineering, Quality and Regulatory Affairs, and promote data-driven decisions while maintaining ISO 10993 alignment and a

Qualifications

• Master's degree in Biology, Microbiology, Life Sciences, or a related discipline.
• Extensive experience in biological and microbiological testing, including method development and validation.
• Solid understanding of regulatory and quality requirements in regulated industries (medical devices/pharma).

Responsabilités

• Lead development, validation, implementation and lifecycle management of biological and microbiological test methods.
• Drive continuous improvement of testing capabilities and laboratory processes.
• Collaborate with Product Engineering, Chemical Laboratory, Quality and Regulatory Affairs on biological endpoint testing and risk assessment.
• Investigate deviations and implement CAPA to ensure timely, sustainable improvements.
• Represent the organization during customer audits and regulatory inspections.

Connaissances

Biological testing

Microbiological testing

Method development

Validation

Troubleshooting

Data analysis

Quality systems

Formation

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

Description du poste

Terumo Europe NV, Leuven-based QR department, seeks a Lab Engineer Microbiology responsible for developing, implementing, coordinating and overseeing biological and microbiological testing to ensure product quality, safety and regulatory compliance across global operations.

You will lead test method development and validation, drive improvements, collaborate with Product Engineering, Quality and Regulatory Affairs, and promote data-driven decisions while maintaining ISO 10993 alignment and a