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Lenexa

    Senior Cleaning Validation Engineer - Lenexa, United States - GBA

    GBA
    GBA Lenexa, United States

    3 weeks ago

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    Description

    Job Summary:


    The Senior Cleaning Validation Engineer will be responsible for providing validation expertise and leadership, coordinating and achieving project deliverables, writing and reviewing protocols, executing protocol execution, and tracking and reporting on cleaning validation status.

    This role will also involve developing and defending scientific protocol rationale, generating final reports, assessing the impact of proposed changes to validated products, supporting commercial investigations and deviations, and maintaining compliance with regulatory requirements.


    Responsibilities:

    • Coordinate and achieve project deliverables to meet customer needs
    • Write and review protocols for cleaning validation
    • Coordinate and perform protocol execution, including field sample collection, statistical analysis, summarizing deviations, and troubleshooting failures
    • Track and report on cleaning validation status throughout the project lifecycle
    • Develop and defend scientific protocol rationale for study design, sampling requirement, and acceptance criteria
    • Generate final reports and compile historical data packages for approval
    • Assess the impact of proposed changes to validated products
    • Support execution of commercial investigations and deviations, including associated corrective and preventive actions (CAPAs)
    • Support internal and external audits
    • Maintain compliance with current applicable regulatory requirements and guidelines (e.g., 21 CFR , EudraLex Annex 15, etc.)

    Qualifications:

    • Bachelor's degree in chemistry, microbiology, engineering, or a related field from a fouryear college or university
    • Minimum 57 years of cleaning validation experience within the pharmaceutical industry
    • Excellent communication skills and the ability to interact with crossfunctional groups at all levels
    • Solid experience in validating cleaning processes
    • Experience in liquid and/or semisolid drug manufacturing is a plus
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