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Braymer

    Validation Engineer - Swiftwater, United States - SSi People

    SSi People
    SSi People Swiftwater, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Experience in cleaning validation in the biologics or vaccine industry to include the following:

    o Experience in authoring, reviewing, executing and approving validation documents.

    o Interface with Quality organization and the ability to defend rationale in validation documents.

    o Ability to develop cleaning cycle and lead the investigation or trouble shooting.

    o Ability to review and analyze data.


    • Cleaning Validation experience

    o Acceptance criteria determination

    o Sampling plans and sample size determination

    o Rinse and Swab sampling experience

    o Bracketing and worse case rating

    o QC testing requirements

    o Dirty hold times and clean hold times

    Basic Qualifications:


    • Experience utilizing Microsoft Word, Excel, and Outlook


    • Experience writing and revising documents (e.g. testing methods, protocols, reports)


    • Experience performing testing in a GMP setting


    • MS Project experience

    Skills


    • Proficiency in utilizing documentation system to author protocols and reports


    • Experience participating in teams and collaborative work environments.


    • Good communication skills (verbal and written), math skills, general computer skills


    • Team environment a must


    • E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process


    • Strong root cause analysis with cGMP experience.

    BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical) with 2+ total years of experience working in a biologic, vaccine or pharma industry

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