Microbiology Lab Engineer

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

• Lead and coordinate the development, validation, implementation, and lifecycle management of biological and microbiological test methods
• Drive continuous improvement of biological and microbiological testing capabilities, methodologies, laboratory efficiency, and processes
• Partner with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs teams on biological endpoint testing and biological evaluation and risk assessment of medical devices under ISO 10993
• Investigate deviations and implement corrective and preventive actions (CAPA)
• Serve as a Subject Matter Expert and key contact for internal and external stakeholders
• Represent the organisation during customer audits and regulatory inspections
• Assess and support implementation of new and updated regulatory requirements, standards, and internal procedures across manufacturing sites
• Contribute scientific expertise to cross-functional improvement initiatives, product development activities, and strategic projects
• Promote quality, collaboration, continuous learning, and operational excellence

Requirements

• 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 modern laboratory technologies and equipment
• Solid understanding of statistical principles and data analysis techniques
• Thorough knowledge of microbiological principles in highly regulated industries, ideally medical devices, pharmaceuticals, biotechnology, or healthcare
• Good understanding of international regulatory and quality requirements, including ISO standards, European and United States Pharmacopoeia requirements, and relevant industry guidelines
• 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
• Comfortable working in an international and cross-functional environment
• Excellent spoken and written English language skills
• Dutch considered a strong advantage

Core Competencies

Demonstrates expertise in biological and microbiological testing methodologies, regulatory compliance, and quality assurance within the medical device industry. Proficient in data analysis, stakeholder management, and continuous improvement initiatives.

Highest-signal resume keywords

• Biological Testing Expertise
• Microbiological Testing Expertise
• ISO 10993 Compliance
• Statistical Analysis
• Regulatory Affairs Knowledge

ATS Optimization Keywords

Hard Skills

• Method Development
• Validation
• Troubleshooting
• Laboratory Technologies
• Data Analysis Techniques
• Microbiological Principles
• Quality Systems
• Product Design Knowledge
• Regulatory Requirements
• CAPA Implementation

Soft Skills

• Analytical Skills
• Problem-Solving Skills
• Communication Skills
• Stakeholder Management
• Continuous Improvement Mindset

Industry Keywords

• Medical Devices
• Pharmaceuticals
• Biotechnology
• Healthcare
• European Pharmacopoeia
• United States Pharmacopoeia
• Quality Assurance
• Laboratory Environment
• Cross-Functional Collaboration
• International Standards