Microbiology Lab Engineer: Method Development & QA

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

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