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    Process Validation Engineer - Philadelphia, United States - a Biopharmaceutical company based out PA

    a Biopharmaceutical company based out PA
    a Biopharmaceutical company based out PA Philadelphia, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Process Validation Engineer (Contract)

    RESPONSIBILITIES

    • Overseeing and reviewing design and construction work related to process improvements in a cGMP manufacturing facility.
    • Supporting startup, Commissioning, Qualification, and Validation (CQV) of process equipment, and developing process technical transfer documents.
    • Collaborating with senior leadership to develop long-term strategic plans aligned with operational strategies for process, facility engineering, and controls.
    • Implementing process improvements, including selecting and modifying new equipment and facilities.
    • Writing, reviewing, and editing technical documents, such as Equipment Specifications, Test Protocols, SOPs, CAPAs, and Change Controls.
    • Revising documents as necessary to accurately reflect current procedures.
    • Reviewing and editing documents created by team members for accuracy, clarity, and consistency.
    • Participating in technology transfer, conference calls, and sharing technical information.
    • Adhering to GMP and SOPs, including GDP, and ensuring data recording compliance with regulatory requirements.
    • Ensuring documentation compliance with internal requirements, FDA, EMA, and ISO standards.
    • Attending weekly management meetings to discuss timelines and priorities.
    • Managing projects to ensure timely initiation and completion.

    QUALIFICATIONS

    • Minimum 2+ years of related BioPharma Life Sciences experience.
    • Experience in process simulation, preparing and checking process deliverables, and participating in design safety reviews and HAZOPs.
    • Desired experience with GMP procedures, including change controls, deviation management, and CAPAs.
    • Extensive knowledge of small-scale cell culture processes and techniques preferred.
    • Cell therapy manufacturing experience is a plus.
    • Experience interfacing with automation, facility design, and mechanical design groups.
    • Experience interfacing with CQV and operations teams.
    • Excellent oral and written communication skills.
    • Strong analytical, presentation, and interpersonal skills.
    • Exceptional attention to detail and follow-through.
    • Effective technical presentation skills.
    • Excellent verbal and written skills in communicating regulatory and technical information.

    EDUCATION

    • Bachelor's or Master's degree in Chemical, Mechanical, Biochemical Engineering, or related discipline.
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