Validation Analyst

Summary

Join Veeva Systems, a leading SaaS company in life sciences, as a Computer Software Validation (CSV) professional specializing in clinical trial software. This role focuses on supporting customer RTSM (Randomization and Trial Supply Management) implementations. You will collaborate with development and project management teams, ensuring requirements are clearly defined, tested, and compliant. Your expertise will be crucial in managing validation testing cycles, maintaining documentation, and providing technical guidance. This Work Anywhere position offers flexibility to work from home or in the office. Veeva is committed to employee success and offers a positive work environment.

Requirements

• 1+ years of experience in a CSV for software
• Working knowledge of software development cycle (SDLC)
• Exceptional attention to detail
• Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels

Responsibilities

• Participate in RTSM requirement gathering sessions with clients and RTSM team members
• Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format
• Ensure requirements are adequately tested following a risk-based approach
• Develop and maintain CSV deliverables, including requirements specifications, test scripts, summary reports, and trace matrices
• Manage Validation testing cycles and resolution of issues and enhancement requests
• Maintain change control documentation to ensure ongoing validation of the RTSM system
• Provide technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements
• Support customers as needed in RTSM validation activities

Preferred Qualifications

Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11

Benefits

Work from home or in the office