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    Senior validation engineer - Indianapolis, United States - Della Infotech

    Della Infotech
    Della Infotech Indianapolis, United States

    2 weeks ago

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    Description

    Job Title:
    Senior Validation Engineer

    Duration: 9 Months Contract


    Location:
    Indianapolis, IN


    Pay rate:
    $ 40/hr

    Intent to convert after 90 days based on performance.

    Pharmaceutical experience is required.


    The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network.

    You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state.

    In this role, you will also create and implement the site s validation strategy.

    What you will do

    Assess and define assigned validation projects. Liaise between engineering and quality assurance throughout validation lifecycle of packaging equipment and data historian network.

    Develop validation strategy based on URS and pFMEA

    Writing, reviewing, and implementing project validation protocols for standard & customized systems.

    Raise discrepancies and closeout test documentation.

    Prepare validation summary reports for completed protocols

    Conduct deviation investigations, such as validation failures, complaints, and hold investigations. To Identify & implement the appropriate corrective actions.

    Applying structured problem-solving tools, work with Operations to resolve technical issues and rationalize impact to validated state.

    Author operational guidance documents (SOP/WI/JA/FORM) and conduct trainings

    Travel to support FAT executions

    Partner with quality assurance team to participate in internal and external audits to defend equipment validation packages including calibration and maintenance


    Education:
    Bachelor of Science Degree in Engineering or another scientific subject area from an accredited College or University


    Experience:


    Minimum of 3 years of validation experience in a regulated industry or equivalent validation experience that included the development and execution of FAT, SAT, and IQ/OQ protocols required.

    Experience with DeltaV or similar automation system preferred.

    Experience working with Trackwise, Maximo, and other electronic document management systems preferred.

    Experience applying Data Integrity Principles (ALCOA) as part of standard work preferred.

    Experience with computer systems validation, cleaning validation, and environmental monitoring preferred.

    Demonstrated understanding of cGMP, GDP, and regulatory requirements for automated systems, CPPs, and CQAs, pFMEAs

    Report this job


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    Position Id:
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