Qualification Engineer

Location: BrusselsDepartment: Quality / ValidationIndustry: Pharmaceuticals / Medical Devices / DiagnosticsAbout the Role:As a Qualification Engineer, you will ensure that all manufacturing equipment, utilities, and facilities remain in a validated and compliant state. You’ll play a key role in qualification and validation activities, support audits, and help shape a harmonized qualification strategy across the site.What You’ll Do:Plan, execute, and document qualification and validation of manufacturing equipment, utilities, computer systems, and facilities (e.g. HVAC).Maintain the qualified state through change control, periodic reviews, and requalification.Develop and implement SOPs, work instructions, templates, and tools for qualification activities.Act as a qualification subject matter expert during internal and external audits (FAGG, FDA, etc.).Stay up to date with global regulations (cGMP, ISO 13485, 21 CFR Part 11) and implement best practices.What You Bring:Master’s degree in Engineering, Pharmacy, or equivalent experience.3–5 years’ experience in qualification/validation within a regulated environment (pharma, medtech, or diagnostics).Strong technical writing and documentation skills.Analytical mindset, organized, and able to work independently.Knowledge of cGMP, ISO 13485, 21 CFR 820, and Part 11.Fluent in English and Dutch (written and spoken).Nice to Have:Experience with IVD manufacturing or diagnostic systems.Familiarity with PCR technologies and regulatory inspections.