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    Biotech Process Engineer - Cambridge, United States - Validation & Engineering Group Inc.

    Validation & Engineering Group Inc.
    Validation & Engineering Group Inc. Cambridge, United States

    2 weeks ago

    Default job background
    Description
    Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

    We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
    • Aseptic Filling Process Engineer
    Qualifications:
    • Bachelor's Degree in Engineering.
    • Minimum of 5 years of experience in the biotechnology industries.
    • Experience in aseptic filling process / manufacturing areas.
    • Experience with Vial Filling Machine (Optima preferred)
    • Must be fully bilingual (English / Spanish) with excellent oral skills.
    • Must be proficient using MS Windows and Microsoft Office applications.
    • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
    • SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
    • Technical Writing skills and investigations processes.
    • Available to work extended hours, possibility of weekends and holidays.
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