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Kalamazoo

    CQV Engineer - Kalamazoo, United States - Katalyst Healthcares and Life Sciences

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    Description
    Responsibilities:
    • Improve the compliance footprint for the automation team by implementing continuous improvement practices for them to follow. These relate to regulatory, corporate and site policies and practices.
    • Update Data Integrity Assessments and route them through change control.
    • Review and route for FS, FAT, and SAT document approval.
    • uthor and route VTP documents for authorization and execution.
    • uthor and route SARR documents for authorization.
    • Monitor the document authorization process, ensuring completion in line with deadlines.
    Requirements:
    • BSc or MSc in Engineering (or equivalent experience).
    • 3-5 years of automation C&V experience.
    • utomation design experience in a pharmaceutical environment.
    • Experience working in a team environment.
    • Excellent English reading, writing, speaking and communication skills required.
    • Professional Engineer license (preferred not required).
    • Experience with the KNEAT electronic document system (preferred not required).