Computer Systems Validation Engineer

Role: Computer System Validation Engineer

(Hybrid- 3 days a week Onsite in San francisco CA) Bridgewater

Contract: 6 months with possible extension\

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 (Preferably Computer, B.Pharma)

* Minimum 6 years of experience in Computer System Validation

* Must know GAMP5 (difference between Category3, 4 and 5).