Validation Specialist

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.