Computer Systems Validation Engineer

Overview

Remote
On Site
Full Time
Part Time
Accepts corp to corp applications
Contract - W2
Contract - Independent

Skills

CSV

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).

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