Validation Engineer
Core
Technical representative for validation activities ensuring compliance with ISO standards, FDA regulations, and customer requirements in a highly regulated healthcare environment.
Role type
Validation Engineer
Builds
Customer validation projects, validation protocols, reports, and supporting technical documentation
Domain
Healthcare / Medical Devices / Pharmaceuticals / Sterilization Services
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol writing and execution, Quality Management Systems knowledge, Analytical and problem-solving skills, Data analysis, Report writing, Equipment qualification support (IQ/OQ/PQ), Calibration management
Preferred skills
Sterilization validation experience, FDA and ISO regulatory knowledge, Equipment qualification project support
Responsibilities
Plan and manage customer validation projects from initiation to completion, Execute validation studies including scheduling processing runs and laboratory testing, Review customer-supplied validation protocols for compliance and feasibility, Collect and interpret validation data, Support equipment qualification activities, Lead improvement projects to enhance efficiency, Act as technical contact for customers and internal stakeholders
Seniority
Mid-level, hands-on IC
