Technicien Qualification Validation H/F
Core
Execute qualification and validation testing for medical device manufacturing equipment and processes to ensure compliance with quality standards and regulatory requirements.
Role type
Technician, Qualification & Validation (Medical Devices/Pharma)
Builds
Sterile injectable aesthetic products (hyaluronic acid fillers)
Domain
Medical Devices / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Qualification/Validation protocols execution, Change Control management, Risk assessment, Gap analysis, Technical report writing, System qualification reviews, Data integrity, ISO 13485/FDA knowledge, GMP compliance
Preferred skills
Professional written English, Team collaboration, Planning and organization, Adaptability
Technologies
ISO 13485, FDA regulations, ISO 9001, GMP, Change Control Systems
Responsibilities
Participate in and execute qualification/validation/revalidation tests for equipment and processes, Coordinate operational activities and task assignment for validation projects, Evaluate validation gaps and lead investigations to determine acceptance, Conduct periodic reviews of qualified system status, Approve technical and validation documents as quality representative, Ensure compliance with engineering standards and SVMP
Seniority
Junior to Mid-level, hands-on IC