Applications Engineer - Irvine, United States - Cynet Systems

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    Job Description

    Job Description

    We are looking for Applications Engineer - Remote / Telecommute for our client in Irvine, CA

    Job Title: Applications Engineer - Remote / Telecommute

    Job Location: Irvine, CA

    Job Type: Contract

    Job Description:

    Pay Range: $58.79hr - $62.79hr

    Responsibilities:

    • Responsible for performing and overseeing the validation of processes, facility, equipment, system, and data cleaning processes.
    • Develop and coordinate execution of protocols for equipment and process validations, prepare final reports following the execution.
    • Assist in the implementation and maintenance of the Validation Master Plan.
    • Configures and tests systems to execute features, integration, and reporting.
    • Design and develop test strategy and methodology for the validation of the products, processes, and equipment.
    • Initiates investigations of problems and deficiencies to ensure an important level of product quality.
    • Establish the metrics and monitor the performance of processes, equipment, and tools to verify their efficiency, initiate re-validations and process improvement as needed.

    Qualifications:

    • Bachelor's degree in a technical field such as computer science, computer engineering or a related field required.
    • 2-4 years experience required.
    • Strong ability to manage and deal with different cultures and nationalities.
    • Substantial understanding and knowledge of enterprise information systems such as ERP, PLM, CRM, QMS, etc (such as JDE, SAP, Pilgrim) preferred.
    • Experience with FDA guidelines for Software Quality and Systems Validation is a plus.
    • Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).Experience in authoring/reviewing/approving validation documentation.
    • Implement and maintain software development lifecycle (SDLC) processes.
    • 3+ years of SQL experience, should be able to write complex queries including, stored procedure, creating indexes, CTE's, Functions, and query optimization.
    • 2+ years of Power BI experience using and exporting the data.
    • Highly Proficient with Microsoft Excel.
    • Proven expertise in usage of MS Office Suite.
    • 2+ years of experience with python good to have. (not required)
    • Ability to adapt to rapidly changing environment.
    • Ability to map, troubleshoot, and optimize interfaces with multiple systems.
    • Experience working in complex, matrixed and global business environment.
    • Ability to develop and maintain business and technical documentation.
    • Develop and execute software test plans, test scenarios, and test cases.
    • Monitor quality assurance standards and ensure that products meet customer and industry requirements.
    • Identify, analyze, and document software defects.
    • Work closely with other engineers and stakeholders to identify areas for improvement.
    • Develop and utilize test automation tools and techniques.
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    Company Description

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