Lyophilization Technician-1400056V

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Description Summary: The Lyophilization Technician is primarily responsible for the preparation of lyophilizers, execution / use of the automated loading and unloading system, and appropriate control and monitoring of the lyophilization cycle. Secondary responsibilities include cross-training in other Manufacturing departments and training others on production-related equipment and processes. This position reports to a Supervisor I/II, Manufacturing. Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): · Monitors each lyophilizer during operation via appropriate checks and documentation. · Performs all aspects of lyophilization preparation such as Clean in Place (CIP), Steam in Place (SIP), and leak tests. · Troubleshoots or repairs mechanical failures / faults with the lyophilization systems. · Coordinates with the Maintenance, Engineering, Chemistry, Quality, R&D, Technical Services, and outside vendors to implement new client cycles / cycle updates, mechanical readiness of the lyophilizers, and troubleshooting of the lyophilization systems. · Trains other departments on lyophilization related activities. · Proactively evaluates system functionality to identify and prevent possible system issues that may result in equipment downtime. · Identifies system malfunctions that require follow up and appropriate communication across shifts and departments to ensure proper equipment readiness. · Assists with process/equipment validation. · Ability to cross-train in other Manufacturing or Maintenance areas and train others on production-related equipment. · Perform Preventative Maintenance on all Lyophilizer equipment including LUAT and TCAR systems. Qualifications Job Requirements (Education, Experience and Qualifications): · High school diploma or GED required with a minimum 6 years of related manufacturing experience or · Associates degree, preferably in a Science or Maintenance/Engineering field, with a minimum of 4 years related manufacturing experience. · Knowledge of PLCs preferred · Ability to read and follow engineering prints and drawings preferred · Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements · Ability to stand and walk for extended periods of time · Ability to lift up to 50 pounds · Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.) · Must be able to perform overhead work (ie: sanitizing walls and ceilings) · Physical coordination/flexibility to allow gowning and routine operations in clean room environments · Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear, respirator, and hearing protection · Dexterity and physical condition to perform some level of repetitive motion tasks · Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable) · Duties may require overtime work, including off-shifts and weekends · Use of hands and fingers to manipulate office equipment is required · Must be able to gown qualify for Grade A/B areas
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