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    Manufacturing validation engineer - North Haven, United States - Syntricate Technologies

    Syntricate Technologies
    Syntricate Technologies North Haven, United States

    1 week ago

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    Description

    Hi,
    We are looking for a Manufacturing Validation Engineer. Please let me know, if interested.
    Manufacturing validation engineer
    North Haven, CT
    Full Time/Contract

    Job duties:

    • Process and equipment qualification (IQ/OQ/PQ).
    • Development of test methods for Design V&V, Process Validation, and Production
    • Validation of test methods
    • Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
    • Authoring/releasing of new test methods and editing/redlining of old test methods
    education/experience
    • This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.
    • Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
    • Clean room environment experience
    • Manufacturing Engineering and automation experience.
    • Experience with Test Method Validation and/or Measurement System Analysis is preferred.
    • Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
    • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
    • Strong organizational skills, detail oriented.
    • Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
    • Ability to work to a deadline and to handle multiple tasks simultaneously.
    Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.

    Thanks & Regards,

    Sushil Kumar Kwatra
    Syntricate Technologies Inc.
    Email to:
    USA)
    MBE & E-Verify Certified
    IT Services & Solutions | IT Staffing Consulting | Software & System Implementation
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