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    Validation Engineer - Birmingham, United States - Advantage Technical

    Advantage Technical
    Advantage Technical Birmingham, United States

    3 weeks ago

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    Description

    Validation Engineer / Specialist

    Position Type: Contract

    Position Location: Birmingham, AL

    Position Salary: $65/HR - $75/HR (Depending on Experience)

    Responsibilities:

    • Support and execute all phases of assigned projects from concept through implementation.
    • Follow GMP regulatory compliance, adherence to the site Qualification & Validation Master Plan (QVMP), Standard Operating Procedures (SOP's) and Business Line Policies/Procedures.
    • Work on multi-faceted projects (Capital, Client and Overhead), supporting multiple tasks/priorities of suitable complexity.
    • Provide support to external departments for tasks that require qualification / validation expertise.
    • Adhere to Plans, SOP's and Packages ensuring regulatory compliance (FDA/EU) with industry standards, practices and trends.
    • Prepare Qualification / Validation Packages (Protocols and Summary Reports) within the assigned/specified area / project ensuring the results / conclusions are accurate and in compliance with Site Plans, Business Line Policies and Procedures
    • Establishes safety as the number one priority through training, actions, and behaviors.
    • Adhere to the Company's safety, health and environmental policies, procedures, and directives.
    • Strong problem-solving and critical thinking skills with demonstrated ability to execute technical programs to achieve established goals; strong organization skills to multiple tasks at differing levels of complexity

    Requirements:

    • Bachelor's degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
    • 3+ years working in the Pharmaceutical Industry performing Qualifications / Validations for new or modified systems
    • Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices (GAMP), and cGMPs
    • Knowledge / hands on experience in setup and operation of Kaye Validator systems.
    • Knowledge/exposure to aseptic pharmaceutical manufacturing process / production / facilities is a plus
    • Knowledge and experience in use of the Kaye validator AVS and Kaye ValProbe Systems for temperature mapping is a plus
    • Experience with implementation and qualification of BAS or BMS Systems
    • Experience with temperature mapping protocol development
    • Knowledge of Aseptic techniques and cleanroom requirements
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