GxP Validation Specialist: SaaS & AI Compliance

Katalyst-Healthcares-; Raleigh (NC); Presencial; USD 85.000 - 125.000; Tempo integral

Resumo da vaga

Katalyst-Healthcares- in Raleigh, NC, is seeking a Validation Specialist to support the implementation, validation, and maintenance of GxP computerized systems in R&D IT and Regulatory Affairs. You will validate SaaS applications and AI models per FDA/EU requirements, and drive CSA/CSV initiatives.

The role requires hands-on CSV/CSA experience, strong technical writing, and collaboration across cross-functional teams to ensure continued regulatory compliance and system integrity.

Qualificações

• Bachelor's degree in Computer Science, Information Systems, or related discipline.
• 3–5 years of CSV/CSA or GxP validation experience.
• Pharma/biotech/medical device industry experience.
• Hands-on with GAMP 5, FDA regulations, EU Annex 11.
• Strong regulatory writing experience.
• Experience validating SaaS and AI/ML models.
• Knowledge of eIFU, regulatory submissions and related processes.

Responsabilidades

• Develop validation strategies for GxP computerized systems per GAMP 5, FDA regulations, and EU Annex 11.
• Apply CSA and CSV principles to software applications.
• Prepare and review validation documentation (Change Controls, Validation Plans, URS, testing documents).
• Develop and maintain SOPs, user guides, admin procedures, and training materials.
• Lead system implementation activities (config, UAT, Hypercare).
• Coordinate project teams across functions and manage stakeholders.
• Drive user adoption via training and change management.
• Maintain validated state through periodic reviews and control changes.
• Validate SaaS apps and AI models per GxP and regulatory requirements.
• Support Regulatory Affairs applications (eIFU, ePI, Regulatory Intelligence).

Conhecimentos

CSV validation

CSA validation

GAMP 5

Regulatory compliance

Technical writing

Formação

Bachelor's degree in Computer Science or related

Descrição da vaga

Katalyst-Healthcares- in Raleigh, NC, is seeking a Validation Specialist to support the implementation, validation, and maintenance of GxP computerized systems in R&D IT and Regulatory Affairs. You will validate SaaS applications and AI models per FDA/EU requirements, and drive CSA/CSV initiatives.

The role requires hands-on CSV/CSA experience, strong technical writing, and collaboration across cross-functional teams to ensure continued regulatory compliance and system integrity.