Labor Engineer

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

• 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
• Coordinate biological endpoint testing and contribute to biological evaluation and risk assessment of medical devices in accordance with ISO 10993
• Investigate deviations and implement effective corrective and preventive actions (CAPA)
• Serve as a Subject Matter Expert and key point of contact for internal and external stakeholders
• Provide expert guidance and 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 the application of modern laboratory technologies and equipment
• Solid understanding of statistical principles and data analysis techniques used to evaluate test performance, interpret results, and support data-driven decision-making
• Thorough knowledge of microbiological principles and their application within highly regulated industries, ideally within medical devices, pharmaceuticals, biotechnology, or healthcare
• Good understanding of international regulatory and quality requirements, including ISO standards, European and United States Pharmacopoeia requirements, and other 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 is considered a strong advantage

Core Competencies

Demonstrates expertise in biological and microbiological testing methodologies, regulatory compliance, and quality systems within the medical device and pharmaceutical industries. Proven ability to lead cross-functional initiatives, drive continuous improvement, and effectively communicate with stakeholders.

Highest-signal resume keywords

• Biological Testing Method Development
• Microbiological Testing Validation
• ISO 10993 Compliance
• Statistical Data Analysis
• Regulatory Requirements Assessment

ATS Optimization Keywords

Hard Skills

• Biological Testing
• Microbiological Testing
• Method Development
• Validation Techniques
• Troubleshooting
• Statistical Principles
• Data Analysis Techniques
• Quality Systems
• Regulatory Compliance
• Laboratory Technologies

Soft Skills

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

Industry Keywords

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