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Marquand

    Validation Engineer - Indianapolis, United States - Procom

    Procom
    Procom Indianapolis, United States

    3 weeks ago

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    Description

    Deviation Investigator Intro:


    As a Deviation Investigator, you will play a critical role in maintaining the integrity and compliance of validation processes within a regulated environment.

    Your expertise in engineering, scientific, or maintenance disciplines will be pivotal in investigating deviations, ensuring adherence to cGMP, GDP, and regulatory requirements, and supporting the validation lifecycle of complex systems.


    Deviation Investigator Job Details:

    In this position, you will be responsible for conducting thorough investigations into validation failures, complaints, and other discrepancies. Your tasks will include developing validation strategies, writing and reviewing validation protocols, preparing summary reports, and implementing corrective actions. You will work closely with the engineering and quality assurance teams to maintain system readiness and compliance.


    Deviation Investigator Mandatory Skills:


    • Bachelor's degree in an engineering, scientific, or maintenance discipline.
    • Minimum of 3 years of validation experience in a regulated industry.
    • Demonstrated understanding of cGMP, GDP, regulatory requirements, CPPs, CQAs, and pFMEAs.
    • Experience with DeltaV or similar automation systems is preferred.

    Deviation Investigator Desired Skills:


    • Proficiency with electronic document management systems such as Trackwise and Maximo.
    • Knowledge of Data Integrity Principles (ALCOA).
    • Experience with computer systems validation, cleaning validation, and environmental monitoring.

    Deviation Investigator Start Date:

    Anticipated start date is 04/16.


    Deviation Investigator Location:

    This is an onsite position located in Indianapolis, Indiana, United States. The role requires a commitment to be onsite Monday through Friday from 8 am to 5 pm.


    Additional Requirements:


    • Exceptional communication skills (9/10).
    • Ability to travel to support FAT executions and participate in audits.
    • Candidates will need to undergo background checks and drug testing.
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