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
