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    Sr. Validation Engineer - Los Angeles, United States - Yoh, A Day & Zimmermann Company

    Yoh, A Day & Zimmermann Company
    Yoh, A Day & Zimmermann Company Los Angeles, United States

    1 month ago

    Yoh, A Day & Zimmermann Company background
    Description
    Our client, a global bio-pharmaceutical company, that specializes in core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines, is actively looking to add a

    Sr. Validation Engineer

    to their team. This position will be on-site in Los Angeles.


    Salary:
    $85,000-$130,000

    Location :
    Los Angeles, CA


    Type :
    Direct Hire


    Shift :
    Monday-Friday: 8:00am-5:00pm


    KEY JOB RESPONSIBILITIES:


    Apply thoughtful understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, project management, and other training.

    Perform a variety of projects in several areas at the same time to support manufacturing and engineering.
    Responsible for planning, scheduling, and leading validation assignments. Must demonstrate planning and coordination.
    Review and change control requests with potential impact to validated state of validation elements, as applicable.
    Lead and interface with team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines)
    Write protocols and reports, execute validation documents regarding acceptability to industry standards (GMPs, FDA Guidelines).

    Guide peers in Validation and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses of test results.

    Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis.
    Use validation test equipment, such as, Kaye Validator and Ellabs loggers to support validation activities.

    QUALIFICATIONS:
    Bachelor's degree in engineering discipline required. Chemical, Mechanical, Electrical Engineering Degree. 3+ years of related experience.
    Experience in manufacturing processes and control systems, cleaning processes, process equipment, facilities and critical support systems.
    Prior experience interacting with the FDA and other regulatory agencies.

    Must have experience, proficiency, and leadership in pharmaceutical/biotech validation elements, including the writing and implementing of protocols and standard operating procedures.

    Must be proficient in more than one validation element.
    Must have a comprehension of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and Technical Service experience.

    Must display a solid technical understanding of the validation element principles and scheduling a series of project technical and project management overviews.

    Must be able to lift, push, pull and carry up to 25 lbs.
    In general, you will have a combination of sedentary work and walking around observing conditions in the facility.
    May work in construction or demolition areas

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