Validation Engineer
Posted
Responsibilities:
Requirements:
- 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.
Requirements:
- 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 21 CFR 820 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.
