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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

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    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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