Validation Engineer

Responsibilities

• Ensure all validation methods, processes, facilities, equipment, and computer systems are designed and validated in compliance with internal requirements and industry standards.
• Support the engineering department by defining validation strategies and preparing detailed validation plans and reports.
• Evaluate change requests and perform impact assessments for process and design change controls.
• Manage the calibration of measuring equipment and test benches, including the approval of calibration certificates and reports.
• Review and approve local operating procedures to ensure continuous compliance of tools and processes.
• Support the investigation and resolution of validation deviations or nonconformances.

Requirements

• University degree in Engineering or a related scientific field.
• 3+ years of experience in validation (design, test methods, equipment, facilities, or computerized systems) within the medical device or pharmaceutical industry.
• Strong knowledge of ISO 13485 and MDSAP.
• Familiarity with EU MDR 2017/745 and European Medical Device Directive 93/42/EEC regarding design control and validation.
• Proficiency in statistics and Six Sigma data analysis.
• Fluent English communication skills (written and spoken).
• Strong problem-solving skills and the ability to work effectively within a team.

Preferred Qualifications

• Knowledge of Gage R&R methodology for method validation.

About the Company

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. With a 70-year legacy of innovation in kidney care, we are dedicated to elevating the dialysis experience through digital solutions and advanced services while investing in the future of vital organ therapies.