QA Qualification Engineer
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About the Role
We are seeking a QA Qualification Engineer to join a Quality Assurance team supporting Commercial, Clinical, and CAR-T operations. This role focuses primarily on facilities and utilities (HVAC, water systems, gas systems), ensuring qualification and compliance across the system lifecycle.
Key Responsibilities
- Provide QA support with a primary focus on facilities and utilities
- Participate in change projects throughout the system lifecycle
- Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, qualification reports) for compliance with regulations and company standards
- Review and approve procedures related to qualification, calibration, maintenance, and lifecycle management of systems
- Ensure deviations related to systems are properly assessed, investigated, and addressed through effective CAPAsMaintain up-to-date knowledge of regulations and industry practices to continuously improve qualification processes
- Support regulatory inspections, customer audits, and internal compliance assessments as an SME on qualification topics
- Collaborate cross-functionally to ensure project timelines and organizational objectives are met
What You Bring
- Bachelor's degree or equivalent
- Medior to senior QA experience in a regulated environment (5+ years for medior, 8-10+ years for senior)
- Experience with QA oversight of facilities and utilities preferred; strong interest also welcome
- Strong quality and compliance mindset
- Strong communication skills, with the ability to constructively challenge while maintaining positive stakeholder relationships
- Fluent English and Dutch (spoken and written)
Details
- Hybrid: 3 days onsite, 2 days from home (more onsite depending on project needs)
- Full-time (100%); 80% may be considered for a strong candidate
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