Ingénieur Qualification Validation H/F
Core
Ensuring the validated state of production equipment and processes for sterile injectable aesthetic medical products through qualification, validation, and quality change control.
Role type
Validation & Qualification Engineer (Pharmaceutical/Medical Device)
Builds
Sterile injectable aesthetic medical products (hyaluronic acid-based)
Domain
Pharmaceutical / Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Qualification/Validation strategy definition, Engineering standards application, Protocol and report writing, Operational coordination, Risk evaluation and investigation, Periodic system review, Data integrity and traceability, Change control management, Quality document approval, Process improvement initiatives
Preferred skills
Process validation experience, Knowledge of FDA/ISO13485/ISO6 requirements, English B2 proficiency
Technologies
SVMP, ISO6, ISO13485, FDA regulations
Responsibilities
Define qualification/validation strategies for changes and revalidations, Apply engineering and validation standards, Write qualification/validation plans and reports, Conduct and coordinate qualification/validation trials, Evaluate validation gaps and lead investigations, Perform periodic reviews of qualified systems, Manage change control processes and training, Approve technical and validation documents, Drive process improvement initiatives
Seniority
Mid-level, hands-on IC