Validation Specialist || Raleigh, North Carolina

Title: Validation Specialist (On-Site Raleigh

Location: Raleigh, North Carolina- Hybrid

The Validation Specialist, Regulatory is responsible for implementing GxP computerized systems for the R&D IT department. A successful candidate will have recent CSA experience, an understanding of relevant US and EU regulations, and familiarity with validating SaaS applications, and AI models. Direct experience with electronic Instructions For Use and electronic Prescribing Information, Regulatory Intelligence, and Regulatory Submission and Deficiency management are preferred.

Validation Strategy

Subject matter expertise with GAMP 5 principles, US Code of Federal Regulations, and EU Annex 11 regulations

Subject matter expertise in computer software assurance (CSA) principles

Ability to review processes and procedures and implement GxP computerized software in a compliant manner

Ability to lead and facilitate meetings, interact with relevant stakeholders, and build strong relationships

This activity constitutes ~10% of the job description

Technical Writing

Ability to write validation documents to support the implementation of software applications including change controls, validation plans, user requirements, and testing documentation

Ability to write training documentation, User and Admin SOPs, as applicable

Experience with electronic validation applications preferred

This activity constitutes ~40% of the job description

System Implementation

Ability to implement GxP computerized systems, including project management configuration, user acceptance testing, and hypercare

Ability to drive user adoption of the new application through training and change management

Ability to maintain the validated state of applications in accordance with policies and procedures

This activity constitutes ~50% of the job description

Technical & Functional Skills

Experience with Computer System Validation, Computer Software Assurance and GxP relevant applications

Experience with writing standard operating procedures, validation deliverables, training material

Experience running projects and strategy initiatives

Minimum Qualifications

Bachelor's Degree in Computer Science / Information Systems or related discipline

3 5 years of experience in a position of equal scope and responsibility

Experience in the pharmaceutical or medical device industry

Preferred Qualifications

Experience with Medical Device Regulatory Submissions and applications used by Regulatory Affairs teams

Experience with CSA validation of SaaS applications

Experience with CSA or CSV validation of AI models

Physical Requirements

This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.

Warm Wishes!
Ravi Kumar || Sr. Technical Recruiter
St. Augustine, FL 32092
Email: ravi.kumar@stellentit.com ||