Microbiology Lab Engineer: CAPA & Regulatory Liaison

Jobtailor; Vlaams-Brabant; Sur place; EUR 75 000 - 110 000; Plein temps

Résumé du poste

Jobtailor seeks a highly capable Biologist/QA specialist to lead and coordinate the development, validation, implementation, and lifecycle management of biological and microbiological test methods within a regulated medical devices environment.

You will drive continuous improvement of testing capabilities, laboratory efficiency, and processes, partnering with Product Engineering, Quality, Regulatory Affairs, and other teams.

Qualifications

• Master’s degree in Biology, Microbiology, Life Sciences, or related discipline, or equivalent laboratory/regulatory experience.
• Strong expertise in biological and microbiological testing, including method development, validation, and troubleshooting.
• Solid understanding of statistical principles and data analysis techniques.
• Thorough knowledge of microbiological principles in regulated industries (medical devices/pharma/biotech).
• Good understanding of international regulatory and quality requirements (ISO standards, USP).
• Broad knowledge of product design, manufacturing processes, and quality systems.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management skills.
• Proactive and continuous improvement mindset.

Responsabilités

• Lead and coordinate development, validation, implementation, and lifecycle management of biological and microbiological test methods.
• Drive continuous improvement of testing capabilities, lab efficiency, and processes.
• Partner with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs for testing and regulatory needs.
• Investigate deviations and implement CAPA.
• Serve as SME and key contact for internal and external stakeholders.
• 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 product development.
• Promote quality, collaboration, continuous learning, and operational excellence.

Connaissances

Biological Testing Expertise

Microbiological Testing Expertise

ISO 10993 Compliance

Statistical Analysis

Regulatory Affairs Knowledge

Formation

Master's degree in Biology / Microbiology or Life Sciences

Outils

Laboratory Technologies

Data Analysis Techniques

Troubleshooting

Method Development

Validation

CAPA Implementation

Description du poste

Jobtailor seeks a highly capable Biologist/QA specialist to lead and coordinate the development, validation, implementation, and lifecycle management of biological and microbiological test methods within a regulated medical devices environment.

You will drive continuous improvement of testing capabilities, laboratory efficiency, and processes, partnering with Product Engineering, Quality, Regulatory Affairs, and other teams.