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Portsmouth

    Validation Engineer III - Portsmouth, United States - LanceSoft

    LanceSoft
    LanceSoft Portsmouth, United States

    1 week ago

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    Description
    Title: Validation Engineer III
    Location:Portsmouth, NH 03801
    Duration: 12 Months

    Description:
    • This role is a senior CSV engineer requirement.
    • CSV /Automation experience of 5+ years
    • Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / Client (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
    • Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
    • Experience working independently as well as in a team-oriented, collaborative environment is essential.
    • Author, Review, Approve and Execute CSV life cycle documentation.
    • Experience working with and programming/commissioning/validating Delta V software platforms.
    • Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation-based systems.
    • Manage, document, and assess the software changes throughout the SDLC following client procedures.
    • Knowledgeable of S88 Batch Standard is preferable.
    • Recipe management DeltaV software development and testing are preferable.
    • MES Recipe authoring and testing is preferable.
    • Implementation and validation of QC system is preferable.
    • Experience with Kneat is preferable.
    • Strong verbal and written communication skills
    • This role is 100% onsite.
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