Laboratory Engineer

Jobtailor; Vlaams-Brabant; Sur place; EUR 65 000 - 95 000; Plein temps

Résumé du poste

Jobtailor is seeking an experienced biology leader to develop and validate biological and microbiological test methods, driving lifecycle management and continuous lab improvement for medical devices. You will partner with engineering, quality and regulatory teams to ensure regulatory compliance and robust testing capabilities.

You will investigate deviations, lead CAPA actions, and represent the company during audits and inspections, while contributing to cross-functional projects and

Qualifications

• Master's degree or equivalent experience in a lab/regulatory environment.
• Strong expertise in biological/microbiological testing and method validation.
• Solid understanding of ISO standards and regulatory expectations.

Responsabilités

• Lead development, validation, implementation and lifecycle management of test methods.
• Drive continuous improvement of biological/microbiological testing capabilities and lab processes.
• Partner with Product Engineering, Quality and Regulatory Affairs on ISO 10993 testing and risk assessment.
• Investigate deviations and implement CAPA.
• Represent the organization during customer audits and regulatory inspections.
• Contribute scientific expertise to cross-functional improvement and strategic projects.

Connaissances

Biological Testing

Microbiological Testing

Method Development

Validation

Troubleshooting

Data Analysis

Regulatory Requirements

Quality Systems

ISO 10993

Stakeholder Management

Cross-functional Collaboration

Formation

Master's degree in Biology or related field

Outils

Laboratory Technologies

Modern Lab Equipment

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 and laboratory processes
Partner with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs colleagues on biological endpoint testing and medical-device biological evaluation and risk assessment 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, method development, and validation, with a strong understanding of regulatory requirements and quality systems in the medical device and pharmaceutical industries. Proven ability to lead cross‑functional initiatives and drive continuous improvement in laboratory processes.

Highest-signal resume keywords

• Biological Testing Expertise
• Microbiological Testing Expertise
• ISO 10993 Compliance
• Statistical Analysis Techniques
• Stakeholder Management

ATS Optimization Keywords

Hard Skills

• Method Development
• Validation
• Troubleshooting
• Data Analysis
• Microbiological Principles
• Regulatory Requirements
• Quality Systems
• Laboratory Technologies
• Product Design Knowledge
• Continuous Improvement

Soft Skills

• Analytical Skills
• Problem-Solving Skills
• Communication Skills
• Proactive Mindset
• Collaboration

Industry Keywords

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