Laboratory Engineer

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