Overview
Skills
Job Details
Computer System Validation Engineer (CSV)
SFO, CA Onsite
Contract
Client : Cellares
Minimum 10+ Years experience required .5 year in Pharma domain
Job Roles and Responsibilities:
* Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Ensure that software is properly validated and compliant with internal and external standards, such as FDA 21 CFR Part 11, GxP, and ISO regulations.
* Prepare and maintain detailed documentation for validation activities, including test plans, test scripts, and final validation reports.
* Document validation results clearly and consistently to ensure compliance with industry standards and regulations.
Requirements:
* Bachelors in any field (computer, B.Pharma)
* Minimum 6 years of experience in Computer System Validation
* Must know GAMP5 (difference between Category3, 4 and 5).