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    Instrumentation Specialist - Brownsburg, United States - Medix

    Medix
    Medix Brownsburg, United States

    3 weeks ago

    Default job background
    Description
    Seeking an Instrumentation Specialist, CQV or Sr. Instrumentation Specialist, CVQ for ATLab Indianapolis, a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals.

    This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability.


    Job Responsibilities:
    Oversee IQ/OQ/PQ for new instrumentsDraft/review/approve documents related to CQV (SOPs, calibration certificates, IQ/OQ/PQ protocols, completed IQ/OQ/PQ reports)

    Equipment/service logs:
    establish, review, maintainURS for equipment: Assist with drafting/review/approvalResponsible for a variety of cGMP and non-cGMP instruments including:Production: preparatory LC, fluid transfer, dispensing, weighing,


    EMQC:

    LC, HPGe, gamma counter, sterility, analytical balances, pipettesHot cells: VPHP, EM, fill/finish, other sensors/controlsSafety: radiation detectors for personnel, surfaces, airGeneral: refrigerators/freezers, incubatorsAssist with cGMP aspects of facilities equipment/sensors/controls: hot cells/cleanrooms/HVAC, temperature/RH, particle counters, fume hoods, access control, etc.

    Work with instrument operators to develop robust protocols for system suitability checks for equipmentAssist with vendor qualificationsTop Priority:
    On-Time Production/Release of Product Batch ReleaseAll tasks from the Setup Phase that continue into Production Phase.
    Carrying out/supervising calibration procedures and equipment maintenance to ensure that instruments maintain their qualified status.
    Preparation of calibration certificates and data reports using appropriate Quality documentation.
    Ensuring that the equipment is calibrated as per specifications and industry standards.
    Oversee warranties, PMs, scheduled recalibration/requalificationScheduling appointments for equipment maintenance and servicing.

    Troubleshooting and repairing equipment and/or supervise outside contractors performing these tasksTesting repaired equipment to verify qualified statusEnsuring a complete stock of backup instruments, spare parts, calibration equipment, other supplies.


    Expert on instrumentation:

    liaison to management/inspectorsWrite protocols for in-house calibrations/qualificationsAnalyze/suggest equipment upgrades and softwareStudy industry guidelines and perform Change Controls to bring Orano Med SOPs into alignment (FDA, USP/EP, ICH, PDA, etc.)Oversee investigations to resolve deviations/OOS/recalls/complaints/FMEAs related to equipment.



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