ORole: Computer System Validation (CSV) - GenAI / CSV)

Location: Raritan, NJ (Hybrid)
Job Type: Contract (6+ Months)

We are seeking an experienced Validation Lead with strong expertise in Computer System Validation (CSV) and Generative AI validation within a GxP-regulated pharmaceutical, biotechnology, or medical device environment.

Required Qualifications

• 3+ years of Computer System Validation (CSV) experience
• Experience validating Generative AI (GenAI) or AI-based solutions in a GxP-regulated environment
• Experience supporting CSV AI projects
• Strong understanding of FDA regulations, GxP, GAMP 5, and risk-based validation
• Experience with the Software Development Lifecycle (SDLC)
• Hands-on experience preparing and executing:
• Validation Plans
• Validation Protocols
• Validation Reports
• Requirements Documentation
• Test Protocols
• Test Summary Reports
• Traceability Matrix (RTM)
• Experience with QA methodologies, UAT, test planning, and compliance documentation
• Ability to provide validation strategy, guidance, and project leadership
• Excellent communication and stakeholder management skills
• Experience working with cross-functional and global teams

Preferred Skills

• Agentic AI
• AI/LLM Validation
• Computer Software Assurance (CSA)
• Quality Management Systems (QMS)
• Pharmaceutical or Life Sciences domain experience

If you have hands-on experience validating GenAI or AI solutions in a regulated GxP environment and are looking for your next opportunity, we’d love to hear from you.

Apply today with your updated resume.

Sumit :: NOBLESOFT
[email protected]

NOBLE-IT

Pay: $40.00 - $50.00 per hour

Work Location: In person