Validation Engineer – Aseptic - Boca Raton - Intellectt Inc

    Intellectt Inc
    Intellectt Inc Boca Raton

    1 day ago

    Pharmaceutical / Bio-tech
    Description

    Hiring for Validation Engineer – Aseptic / Sterile Injectables

    Location: Boca Raton, FL (Onsite)

    Employment Type: Contract (W2)

    Position Summary

    Seeking a Validation Engineer with hands-on experience in aseptic processing and sterile injectable manufacturing. This role will support process validation activities with a strong focus on vial filling and fill-finish operations in a cGMP-regulated environment.

    Key Responsibilities

    • Support aseptic process validation for sterile injectable and vial filling operations
    • Execute and document media fills, process validations, and cleaning validations
    • Prepare and review IQ/OQ/PQ protocols and validation reports
    • Support validation of filling, stoppering, and capping processes
    • Participate in deviation investigations, CAPA, and risk assessments
    • Ensure compliance with cGMP, FDA, and regulatory standards
    • Collaborate cross-functionally with Manufacturing, QA, and Engineering

    Qualifications

    • 4–8 years of validation experience in sterile injectable manufacturing
    • Hands-on experience with aseptic vial filling and fill-finish operations
    • Strong knowledge of media fills and aseptic validation requirements
    • Solid understanding of cGMP and FDA regulations
    • Strong technical writing and documentation skills

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