Computer Systems Validation Engineer

Overview

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

Skills

IQ
OQ
PQ
GxP
ISO 9000
Documentation
Test Plans
Test Scripts
Regulatory Compliance
Pharmaceutics
Computerized System Validation
GAMP
SANS
SCADA

Job Details





Role: Computer System Validation Engineer

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

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).



Preferred: Experience with SCADA systems.


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