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The GMP Systems group is a compliance function within the Cellular Processing Facility (CPF). The CPF is a manufacturing organization that executes process operations in the production of modified cellular products for patients participating in cell therapy clinical trials in the Fred Hutch Cancer Research Center. GMP Systems is responsible for developing and administrating a variety of quality systems to ensure compliance with applicable regulations. The groups focus is on all aspects of GMP equipment life cycle, as well as on raw materials inventory management.
The GMP Systems Specialist II will primarily address facilitation of process equipment commissioning and qualification, routine calibration, maintenance, and repairs of GMP manufacturing and laboratory equipment to ensure a continued state of regulatory compliance and continuity in support of clinical manufacturing operations.
Track, schedule and ensure on-time completion of routine equipment service events.
Establish and manage service providers and vendor contracts related to equipment maintenance, calibration, and repair.
Maintain pertinent documentation and equipment files, including drawings, O&M manuals, equipment logbooks and service records in accordance with GMP record keeping practices.
Facilitate shipment of equipment serviced off-site.
Identify and communicate deviations from established procedures.
Respond to notifications of malfunctioning equipment, participating in investigation to diagnose cause, coordinate repairs by Fred Hutch Engineering or other service provider, as necessary.
Facilitate verification of restored performance following equipment repairs, to ensure equipment is suitable to return to service.
Support development of equipment specifications (user requirements) for new equipment, participate in equipment selection, procurement, installation, etc.
Facilitate commissioning and qualification of new equipment.
Author equipment validation protocols and reports. Assist in execution of validation protocols. Investigate and document validation deviations.
Support development of operation and maintenance Standard Operating Procedures (SOP) for new equipment.
Assist manufacturing staff with troubleshooting and/or continuous improvement of equipment operations.
Provide additional support for GMP equipment life cycle, as needed.
BS in a Biological Science or Engineering, or relevant experience in biologics manufacturing and/or cellular therapeutics processing.
Experience working in a regulated (GxP) environment, including a thorough understanding of GMP record keeping and documentation practices.
Experience creating and revising SOPs.
Strong troubleshooting and problem solving skills.
Must be able to work efficiently, with strong attention to detail in a regulated environment.
Must be able to communicate effectively in a diverse team environment in support of team goals.
Must demonstrate solid time management and organizational skills, with good verbal and written communication.
Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all required Personal Protective Equipment (PPE).
Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.
Experience with basic Microsoft Office Software (Word, Excel, Visio, etc.)
Experience working as a customer service provider.
Experience working in cellular therapeutics and/or biologics manufacturing environment.
Experience creating equipment SOPs for GMP clinical process equipment, and other GMP documents (reports, user requirements, etc.)
Experience in developing and authoring equipment validation protocols and reports
Experience in assisting with facilitation of facility start-up and shut down activities
Strong administrative and logistics skills required to track a large variety and volume of tasks simultaneously.
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.