Validation Engineer

Responsibilities:

• Execute comprehensive verification of digital infrastructure and automated platforms.
• Generate technical specifications and operational flowcharts alongside hazard evaluations.
• Draft formal validation strategies as well as testing scripts and final summary data.
• Uphold strict adherence to FDA regulatory standards for all manufacturing hardware and digital tools.
• Partner with internal departments to define and record necessary functional parameters.
• Lead various high-stakes initiatives simultaneously under tight deadlines.
• Navigate shifting business needs while maintaining high output with little oversight.

• A minimum of five years dedicated to verifying digital systems within the medical technology sector.
• Proven background in software quality oversight and lifecycle testing.
• Medical Software and Lifecycle testing experience.
• Extensive familiarity with CFR compliance and medical manufacturing quality frameworks.
• Exceptional aptitude for resolving complex technical hurdles and making data-driven choices.
• Effective communication style for both independent work and group dynamics.
• Undergraduate or advanced degree in a physical science or engineering discipline.
• Practical experience managing Corrective and Preventive Actions (CAPA) and risk mitigation.
• Functional knowledge of metrology and the use of specialized gauging equipment.
• Proficiency in professional scheduling tools such as Smartsheet or Microsoft Project.
• Refined social skills and the ability to build rapport with diverse technical teams.