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    Validation Engineer - Ayer, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Ayer, United States

    4 weeks ago

    Default job background
    Description
    Responsibilities:
    • ct as the project lead for qualification of QC equipment and its associated software
    • Design, execute, manage, and implement QC instrument/software qualification documents such as (but not
    • limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ
    • protocols, software test scripts, configuration specifications, risk assessments, qualification summary reports
    • uthor/execute computer system validation scripts using an electronic validation database (ALM), or paper-based
    • Own change controls specific to the qualification of QC instruments and its associated software
    • Update the asset management database to reflect new assets, calibrations, preventative maintenances
    • uthor instrument operational SOPs as needed
    • Coordinate/interface/host vendors on site
    • Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive
    • ctions (CA/Client)
    • cts as the liaison between Digital Plant (IT) and lab departments
    • Execute periodic assessments/decommissioning, as needed.
    Responsibilities:
    • Bachelor's degree in relevant scientific, engineering, or computer-based area, with minimum of 5 years' experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience
    • Quality management system experience including: document control/management, change controls,
    • investigations, deviations, electronic validation databases, asset management database
    • Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP,
    • electronic record/electronic signature, data integrity, disaster recovery
    • Incumbents must have demonstrated experience in solving complex technical issues and have the skills and
    • understanding to troubleshoot process defects
    • Demonstrated success in cross functional influencing, strong communication, and collaboration skills
    • Working knowledge of laboratory systems such as: Empower, NuGenesis, and other software programs, including
    • Microsoft Office Applications, preferred.
    • Must have computer system validation experience
    • Must have equipment validation experience
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