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Framingham

    Senior Commissioning Engineer - Framingham, United States - TalentBurst

    TalentBurst
    TalentBurst Framingham, United States

    1 month ago

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    Description

    Position: Principal Commissioning/Validation Engineer III, Req#: SNFIJP

    Location: Framingham, MA (100% onsite)

    Duration: 6 Months Contract

    Job Description:

    Education and Experience:

    • BSc/BEng plus previous experience in the CQV field or equivalent combination of education and experience.
    • Experience in the pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
    • Areas of experience: plant utilities, clean utilities, CIP, SIP, Fill Finish, HVAC, Filling lines, CTUs, component prep equipment, formulation.
    • Well-developed communication skills, both verbal and written.
    • Years of Experience: 6 - 9 Years.
    • Excellent oral and written communication
    • Ability to effectively manage time and prioritize tasks independently
    • Excellent organizational skills
    • Ability to manage day-to-day operations in a fast-paced environment
    • Ability to effectively manage several tasks simultaneously
    • Must be self-motivated and have a proven ability to work in a team environment

    Roles and Responsibilities:

    • Writes and executes commissioning, qualification, & validation protocols for facilities utilities, equipment, and computerized systems
    • Writes final reports
    • Resolves protocol discrepancies and deviations
    • Review vendor-generated validation protocol packages.
    • Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practices.

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