Validation Specialist

Job Description:

Validation Specialist, Regulatory

Work Schedule: Monday to Friday

Work Arrangement: Hybrid, 3 days in office

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.