Senior Validation Engineer
Core
Execute validation and qualification activities for processes, equipment, systems, and facilities to ensure regulatory compliance and operational effectiveness.
Role type
Senior Validation Engineer (Science/Tech/Engineering Path)
Builds
Validated manufacturing processes, equipment, and systems for medical device and eye health products
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol design and execution, risk assessment, data analysis, change control review, deviation handling, GxP compliance, aseptic process support, technical reporting
Preferred skills
Pharmaceutical/biologics/medical device environment experience, CAPA and quality management systems, statistical analysis (Minitab), temperature mapping and thermal validation, sterilization validation (E-Beam, EO, steam), project management
Technologies
Minitab, thermocouple data loggers, E-Beam, EO, steam sterilization systems
Responsibilities
Plan, execute, and document validation studies; conduct risk assessments and analyze data; review and approve change control documentation; handle deviations; author complex validation protocols and technical reports; perform process qualification for new equipment and technologies; support aseptic process management; participate in product transfers and launches
Seniority
Senior, hands-on IC
