Validation Specialist

Katalyst-Healthcares-; Raleigh (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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).

Skills

CSV validation

CSA validation

GAMP 5

Regulatory compliance

Technical writing

Education

Bachelor's degree in Computer Science or related

Job description

Summary :

The Validation Specialist will support the implementation, validation, and maintenance of GxP computerized systems within the R&D IT and Regulatory Affairs environment. The ideal candidate will have hands‑on experience in Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP 5, and regulatory compliance, with a strong understanding of US and EU regulations. Experience validating SaaS applications and AI-based models is highly preferred.

Roles & Responsibilities :

• Develop and implement validation strategies for GxP computerized systems in compliance with GAMP 5, FDA regulations, and EU Annex 11.
• Apply Computer Software Assurance (CSA) and Computer System Validation (CSV) principles to software applications.
• Prepare and review validation documentation, including Change Controls, Validation Plans, User Requirements Specifications (URS), and testing documents.
• Develop and maintain SOPs, user guides, administrator procedures, and training documentation.
• Lead computerized system implementation activities, including system configuration, User Acceptance Testing (UAT), and post‑implementation support (Hypercare).
• Manage system implementation projects, stakeholder coordination, and cross‑functional collaboration.
• Drive user adoption through training, communication, and change management activities.
• Maintain the validated state of computerized systems through periodic reviews, change control, and compliance activities.
• Validate SaaS applications and AI models in accordance with applicable GxP and regulatory requirements.
• Support Regulatory Affairs applications, including electronic Instructions for Use (eIFU), electronic Prescribing Information, Regulatory Intelligence, and Regulatory Submission Management.

Education & Experience :

• Bachelor's degree in Computer Science, Information Systems, or a related discipline.
• 3–5 years of relevant experience in Computer System Validation (CSV), Computer Software Assurance (CSA), or GxP computerized systems.
• Experience working in the pharmaceutical, biotechnology, or medical device industry.
• Hands‑on experience with GAMP 5, FDA regulations, and EU Annex 11.
• Strong technical writing experience, including validation documents, SOPs, testing protocols, and training materials.
• Experience with SaaS application validation and system implementation.
• Knowledge of project management, system configuration, UAT, and change management.
• Experience with Medical Device Regulatory Submissions and Regulatory Affairs applications.
• Experience with CSA validation of SaaS applications.
• Experience with CSA or CSV validation of AI/ML models.
• Familiarity with electronic Instructions for Use (eIFU), electronic Prescribing Information, Regulatory Intelligence, and Regulatory Submission and Deficiency Management.