Specialist, Validation
Core
Planning and execution of qualification and validation measures for medical devices, systems, software, and processes in compliance with GMP and regulatory standards.
Role type
Specialist, Validation (Quality Engineering)
Builds
Qualification and validation documentation, risk assessments, and validated processes for medical technology products.
Domain
Medical Devices / Biotechnology / Regulatory Compliance
Required skills
GMP compliance, Validation planning and execution, Risk assessment (FMEA), Software validation, Regulatory knowledge (ISO 13485, 21 CFR 820, MDR), Documentation management, Process improvement.
Preferred skills
Change control, Cross-functional collaboration, Quality methods (8D, CAPA, APQP), Analytical thinking.
Technologies
GAMP, FMEA, ISO 13485, 21 CFR 820, MDR 2017/745, GxP
Responsibilities
Plan and execute qualification and validation measures for devices, systems, and software; Organize and moderate GMP risk assessments and FMEA; Create and maintain GMP-compliant validation documentation; Support projects involving new equipment and technical process changes; Monitor and evaluate applicable regulations and standards.
Seniority
Specialist, hands-on IC