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    Principal Validation Engineer - Fort Wayne, United States - Cardinal Health

    Cardinal Health
    Cardinal Health Fort Wayne, United States

    3 weeks ago

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    Description


    The Senior Validation Engineer is responsible for supporting the validation program for Cardinal Health's Nuclear and Precision Health Solutions (NPHS) organization.

    Reporting to the Manager of Validations, this position will provide guidance on

    validation/qualification


    initiatives to project teams, while also supporting day to day activities within the NPHS organization to ensure existing systems remain in a validated state.

    This position will develop and review protocols for new and existing cGMP systems, including manufacturing equipment, laboratory instrumentation, and processes, across our network of manufacturing facilities.


    Anticipated salary range:
    $78, $117,705.00

    Benefits:
    Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
    Medical, dental and vision coverage
    Paid time off plan
    Health savings account (HSA)
    401k savings plan
    Access to wages before pay day with myFlexPay
    Flexible spending accounts (FSAs)
    Short- and long-term disability coverage
    Work-Life resources
    Paid parental leave
    Application window anticipated to close:

    05/21/2024 *if interested in opportunity, please submit application as soon as possible.
    Responsibilities
    Assure compliance of validated systems for GMP manufacturing facilities
    Author, execute, review, and summarize commissioning and qualification protocols for GMP systems including manufacturing equipment, laboratory instruments, utilities, spreadsheets, computer systems and processes
    Author user requirement specifications for new equipment
    Provide general technical advice on new equipment, and modifications to existing equipment, to ensure

    validation/qualification

    status is maintained in a state of control
    Provide both on-site and remote validation support to manufacturing facilities and provide technical assistance to site personnel
    Ability to multi-task on multiple projects while supporting day to day validation requests from 30+ manufacturing sites
    Work cross functionally within the organization to ensure a cohesive approach to validation is maintained
    Stay abreast of industry trends in validation and expectations of regulatory agencies to improve the validation program
    Identify and implement improvements in the validation program including procedures, protocols, reports, and systems
    Qualifications
    Bachelor's degree in Engineering or a Physical Science preferred
    2-4 years of relevant validation experience preferred
    Knowledgeable in FDA or ICH qualification preferred
    Experience in Biotech, Pharmaceutical or Medical Device operations including protocol development and field execution, preferred
    Experience with GMP manufacture of radio pharmaceuticals, preferred
    Excellent communication and interpersonal skills preferred
    Proficient in Microsoft Office preferred
    What is expected of you and others at this level
    Applies knowledge and a solid understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
    Contribute to the development of policies and procedures
    Works on projects of a large scope
    Develops technical solutions to a wide range of issues. Solutions are innovative and consistent with organization objectives
    Completes work with some oversight, receives guidance on new projects
    Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
    Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background.

    We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day.

    Cardinal Health is an Equal Opportunity/Affirmative Action employer.

    All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

    Fill out your area of interest and/or location in the fields below to receive job alerts whenopenings become available. You may also opt in to receive additional recruitment communications fromus.

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    You may opt-out of receivingCardinal Health direct text message communications at any time by typing STOP to a text message youreceive from Cardinal Health or contacting
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