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    Validation Engineer - Los Angeles, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Los Angeles, United States

    4 weeks ago

    Default job background
    Description
    Responsibilities:
    • Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
    • Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
    • Perform testing of the entire SDLC, including version/change control and new software rollouts.
    • Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
    • Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
    • Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO
    • BS in Engineering, Science or equivalent technical degree.
    • 3-5 years' experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
    Requirements:
    • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
    • Excellent written and verbal communication skills; excellent technical writing skills.
    • Strong interpersonal skills and the ability to work in a team environment.
    • Ability to work effectively in a fast paced multitasking environment.
    • Strong working knowledge of FDA and cGMP regulations and documentation practices.
    • Proficient in Microsoft Word, Excel, PowerPoint.
    • Working for multiple clients through out the region.
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