CSV/ QMS/ Validation Specialist

Agama Solutions • San Jose, CA

1d • Remote

About The Position

This is a 12-month contract role for a Validation Specialist with strong expertise in ETQ Reliance, Computer System Validation (CSV), and Quality Management Systems (QMS) within regulated Life Sciences environments.

Requirements

• 5+ years of Computer System Validation (CSV) experience in Pharma, Biotech, Medical Device, or Life Sciences.
• 3+ years of hands-on experience with ETQ Reliance.
• Strong knowledge of QMS, FDA regulations, GxP, 21 CFR Part 11, and data integrity.
• Knowledge of SDLC, Agile/Scrum, software testing, defect management, and release processes.

Nice To Haves

• Experience with GAMP 5, SaaS/cloud validation, data migration, and system integrations.

Responsibilities

• Creating and executing validation documents including URS, FS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports.
• Supporting ETQ Reliance implementations, upgrades, enhancements, integrations, and testing.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed