Senior Commissioning Engineer - Framingham, United States - TalentBurst

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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: - 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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