About the position as a Quality Engineer, specializing in Validation and Automation, you will play an important role in ensuring the validated status of all systems, methods, processes at any time during the product lifecycle. Your responsibilities include:

• organizing and managing all validation activities to meet regulatory standards and regulations;
• reviewing and approving validation documentation (systems, methods & processes) to ensure compliance with all applicable standards and regulations;
• participating in development and improvement projects to ensure that IVD software and automation systems meet customer expectations, business and regulatory requirements.

Your Profile

• Education: Master’s degree in Pharmacy, (Bio)-Engineering/Chemistry or Biology.
• Experience: at least 5 years in a GxP environment, preferably in QA within the pharma, biotech or medical device industry, minimum 5 years specifically in validation. Process validation experience is a plus.
• Expertise: comprehensive knowledge of global validation requirements, design control standards and specific software related regulatory requirements.
• Technical skills: familiar with production, QC processes, utilities and project management.
• Communication: strong presentation skills, with fluency in Dutch and English.
• Personal qualities: you have a straightforward approach and work organised, accurate, practical with a strong ream-oriented mindset.