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Validation Engineer - Argus/AERS
Validation Engineer
Palo Alto, CA

USDM validation analysts will support clients on a variety of compliance initiatives -  Looking for resources with Argus/AERS experience.

Job Description
•    The validation analyst will provide an advisory role as needed.  This may include:
o    Advising clients on assigning proper risk to computer systems
o    Advising clients on how to meet compliance requirements.
o    Advising clients on developing test that provide adequate compliance coverage as well as thoroughly tests business requirements.
•    Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements.
•    Work with client business functions and subject matter experts to develop User Requirements, Functional, and Design Specifications to establish hardware/software requirements
•    Develop test / validation scripts based on software / hardware design / configuration
•    Develop Installation tests / qualifications scripts based on Design
•    Develop Operation tests / qualifications scripts based on functional requirements
•    Develop Performance tests / qualification scripts based on configuration
•    Interact in a team environment, managing tasks and escalating issues as needed.

 

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