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    Validation Engineer - New York, United States - Premier Life Sciences LLC

    Premier Life Sciences LLC
    Premier Life Sciences LLC New York, United States

    2 weeks ago

    Default job background
    Description
    Not For C2C Candidates Please do not apply even not enquire


    Job Title:
    CQV Validation Engineer


    Location:
    Countrywide USA

    Contract Duration: 12+ months

    Pay:
    Negotiable on w2 without any benefits


    Responsibilities:
    Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
    Running test scripts and documenting results
    Adherence with project schedule for all assigned activities
    Maintaining clear, detailed records qualification and validation
    Documenting impact and risk assessments as part of a team
    Completing user interface testing, software verification, and complete alarm testing on automated systems
    Developing, reviewing, and executing testing documentation
    Making recommendations for design or process modification based on test results when executing test scripts
    General understanding of capital equipment implementation and process knowledge
    Understanding validation documents, URS, IQ, OQ, PQ


    Requirement:
    Demonstrated experience in leading CQV activities specific to expertise in Facility and Utility qualification. Including qualification of Cleanrooms (including EMPQ), Warehouse, Compressed Gases, WFI, etc.
    Proficiency using PC and Microsoft Office tools
    Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
    GMP and Good Documentation Practice
    Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
    Basic skills with EXCEL and PowerPoint
    Strong interpersonal skills and clear communication capabilities
    Experience with and tolerance for high levels of challenge and change
    Experience in GMP regulated environment
    Capable of working on assigned tasks without mentorship
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