Quality and Validation Engineer

We are seeking a Quality Assurance & Validation Specialist to help ensure that all biomedical products are manufactured, packaged, stored, and distributed in full compliance with current Good Manufacturing Practices (cGMPs).You’ll join a collaborative team and report to the Quality and Compliance Manager Biomedical to uphold quality and drive improvements across our operations.AREA OF RESPONSIBILITY AND RELATED TASKS:• Quality Assurance· Disposition of finished product batches & preparation of certificates of analysis· Incoming release of materials and packaging components· Investigation and resolution of non-conformances, deviations, and complaints· Approval of change controls and supplier qualifications· Management of specifications, QMS documentation and training program· Performing internal audits· Support during customer and authority audits, including CAPA follow-up· Documentation support towards customers• Validation· Development of validation masterplans, protocols (IQ/OQ/PQ) and related documentation· Execution of validation tests and coordination with external partners· Oversight of process validation activities and QC results· Ownership of re-qualifications and centralized validation archive· Contribution to risk assessments (FMEA)PROFILE· 2–3 years of experience in the (bio)pharmaceutical industry with working knowledge of GMP (EU & US)· Skilled in root cause analysis and structured problem-solving· Strong communicator with the ability to influence and collaborate across teams· Proficient in Dutch and English Organized, detail-oriented, and proactiveWE OFFER THE OPPORTUNITY AND CHALLENGE· Impact: Your expertise will directly shape product quality and validation, fueling innovation in life sciences.· Growth in a Global Leader: Be part of an international organization recognized for its pioneering role in gelatin and collagen for biomedical applications.· Learning That Lasts: Expand your skill set in GMP compliance, Quality Management Systems and validation technologies in a supportive environment.