• IT Validation Specialist

    Posting Date 1 day ago(3/19/2019 10:29 AM)
    Requisition ID
    Job Location(s)
    Bloomington IN United States
    Position Type
    Full Time
    Cook Medical Holdings
    Information Technology
  • Overview

    The Information Technology System Validation specialist assists IT Management in executing and maintaining the global computer validation process.


    • Complete projects as directed by IT management
    • Provide assistance to IT teams in the completion of Validation documentation
    • Complete internal review of validation documentation produced by IT teams
    • Collaborate with other Cook functional units (engineering, quality, etc.) as needed
    • Collaborate with internal or external Cook IT team members
    • Coordinate multiple projects at one time and provide regular reports to management
    • Maintain an excellent understanding of global IT and quality system procedures
    • Provide and maintain communication among IT teams and management
    • Maintain understanding of industry standards and best practices for computer system validation

    • Train and facilitate global adoption of the validation process
    • Subject matter expert in the software validation life cycle documentation
    • Must work and interact effectively and professionally with and for others to achieve company goals
    • Must strictly adhere to safety requirements
    • Maintain regular and punctual attendance
    • Must maintain company quality and quantity standards
    • Must have effective oral and written communications throughout various levels of the global organization
    • Ability to work in collaborative and independent work situations and environments with minimal supervision
    • Ability to remain calm and receptive in fast paced situations


    • Associates degree required, Bachelor's preferred
    • Experience with SDLC in a regulated industry

    • Knowledgeable in industry standards and best practices for computer software validation
    • Proficient/expert in Microsoft Office applications
    • Business Objects experience preferred
    • Experience in global coordination of projects

    • Proficient in reading, writing and speaking the English language


    Physical Requirements/Work Environment

    • General office environment
    • Sits for extended periods
    • Requires close visual acuity when working with computers, etc.
    • Requires occasional early morning or late evening teleconferences
    • International and domestic travel as required


    Qualified candidates must be legally authorized to be employed in the United States.

    Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.


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