Biological Testing Engineer: Microbiology & ISO Compliance

Jobtailor; Vlaams-Brabant; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Jobtailor is seeking a Senior Bio/MB Scientist to lead the development, validation, and lifecycle management of biological and microbiological test methods for medical devices. You will drive continuous improvement of testing capabilities, coordinate endpoint testing, and contribute to regulatory risk assessment.

The role requires a Master’s degree in Biology or related field, strong expertise in microbiological testing, and experience with ISO standards and regulatory guidelines.

Qualifications

• Master's degree or equivalent experience in a laboratory, quality, or regulated environment.
• Strong expertise in biological and microbiological testing, including method development and validation.
• Good understanding of ISO standards and regulatory guidelines.

Responsabilités

• Lead and coordinate development, validation, implementation, and lifecycle management of biological and microbiological test methods.
• Drive continuous improvement of testing capabilities, methodologies, laboratory efficiency, and processes.
• Coordinate biological endpoint testing and contribute to biological evaluation and risk assessment of medical devices per ISO 10993.
• Investigate deviations and implement CAPA.
• Serve as SME and point of contact for stakeholders.
• Provide expert guidance and represent the organisation during customer audits and regulatory inspections.
• Assess and support regulatory requirements across manufacturing sites.
• Contribute scientific expertise to cross-functional improvement initiatives and strategic projects.
• Promote quality, collaboration, continuous learning, and operational excellence.

Connaissances

Biological Testing

Microbiological Testing

Method Development

Validation Techniques

Troubleshooting

Statistical Principles

Data Analysis Techniques

Quality Systems

Regulatory Compliance

Laboratory Technologies

Formation

Master's degree in Biology / Microbiology / Life Sciences

Description du poste

Jobtailor is seeking a Senior Bio/MB Scientist to lead the development, validation, and lifecycle management of biological and microbiological test methods for medical devices. You will drive continuous improvement of testing capabilities, coordinate endpoint testing, and contribute to regulatory risk assessment.

The role requires a Master’s degree in Biology or related field, strong expertise in microbiological testing, and experience with ISO standards and regulatory guidelines.