Ingénieur équipements & qualification H/F
Core
Lead the equipment qualification process for R&D sterile injectable products in the medical aesthetics domain.
Role type
Senior IC Quality/Validation Engineer (Equipment Qualification)
Builds
Qualified R&D equipment and systems for sterile injectable aesthetic treatments
Domain
Pharmaceutical / Medical Devices / Regulatory Compliance
Deliverable
infrastructure
Required skills
Equipment qualification strategy, Site Validation Master Plan (SVMP) management, Change Control management, Technical documentation, Regulatory monitoring, Project coordination, Commissioning/Qualification testing
Preferred skills
Stakeholder management, Team training and mentoring, Analytical synthesis
Technologies
GxP standards, Change Control systems, Validation software
Responsibilities
Define equipment qualification strategies, Develop and deploy qualification standards, Monitor regulatory updates, Train team members on qualification processes, Coordinate Change Control for complex systems, Execute commissioning and qualification tests
Seniority
Senior, hands-on IC
