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    Risk Engineer - Frankfurt am Main, Deutschland - Darwin Recruitment

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    Ganztags
    Beschreibung

    Writing of the corresponding qualification documents such as VP, IQ, OQ, PQ and PPQ protocols and reports, risk assessments, and development protocols.

    Providing support for the development of user requirements and functional specifications.
    Actively participating in all phases of validation projects in accordance with the client needed. Evaluating projects and providing technical information to others.
    Recommending to management as to the acceptance and release of qualified equipment/ facilities, services and/or systems.

    Supporting the generation and execution of all documentation related to demonstration batches, thermal studies, validation studies for equipment, engineering test runs, development studies.

    Reviewing technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Batch Production Records, ensuring any document changes meet quality and validation requirements and are in full compliance with regulations, standards, and regulatory compliance issues.

    Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy).
    Hands on commissioning, qualification and validation experience in the following disciplines is needed:
    Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems)
    Computer software validation

    Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.

    Experience with Microsoft Office Suite.
    Fluency in English and German is a must.


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