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    Senior Validation Engineer - New York, United States - a Medical Devices company in MA

    a Medical Devices company in MA
    a Medical Devices company in MA New York, United States

    1 week ago

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    Description
    Senior Validation Engineer


    RESPONSIBILITIES

    Leading start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes.

    Leading the delivery of validation within complex, capital projects overseeing engineering, quality, and compliance aspects of validation.
    Authoring, executing, and summarizing qualification and validation protocols.
    Conducting Risk / Impact assessments and establishing system boundaries.
    Ensuring protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
    Coordinating the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
    Initiating and/or providing validation input on quality systems such as CAPAs and change controls.
    Responsible for other duties and projects as assigned.


    RESPONSIBILITIES
    Minimum 8+ years of validation experience in pharmaceutical, medical device or FDA regulated environments.
    Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations.
    Ability to initiate, manage and close quality systems such as change control, CAPA and deviation management.
    Detailed experience performing root cause analysis investigations for deviations and non-conformances having technical scope.
    Excellent written and verbal communications skills.
    Solid understanding of quality risk management principles and statistical concepts as applicable to area of responsibility.
    Subject matter expert on regulations and best practices pertaining to validation.

    Practical application and knowledge of ISO 13485, GHTF Process Validation Guidance and other applicable standards used in the medical device manufacturing.


    EDUCATION
    B.S. degree in Engineering or related discipline
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