Job ID 11022
Type Regular Full-Time
Company Fred Hutchinson Cancer Research Center
Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The GMP Systems Specialists group is a compliance function within the Cellular Processing Facility (CPF) that supports the manufacture of T-cell and stem cell therapeutic products for clinical trials. This group is responsible for developing and administrating a variety of quality systems to ensure compliance with applicable regulations, including facilitation of GMP equipment qualification, calibration/maintenance and repair, raw materials inventory management, training, cleanroom environmental controls, etc.
The GMP Systems Specialist will primarily focus on the facilitation of routine calibration, maintenance and repairs of GMP manufacturing and laboratory equipment to ensure a continued state of regulatory compliance and continuity 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 that is serviced off-site.
* Identify and communicate deviations from established procedures.
* Respond to notifications of malfunctioning equipment, facilitate investigation to diagnose cause, coordinate repairs by FHCRC 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.
* Support development of operation and maintenance SOP’s 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.
* Bachelor’s Degree in a biological science and at least 6 months of related lab experience. Experience in lieu of degree acceptable.
* Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
* Strong attention to detail.
* Strong troubleshooting and problem solving skills.
* Experience working as a customer service provider.
* Background in biologics or cellular therapeutics.
* Experience working in a regulated (GxP) environment, including a thorough understanding of GMP record keeping and documentation practices.
* Strong administrative and logistics skills required to track a large variety and volume of tasks simultaneously.
* Experience with basic Microsoft Office Software (Word, Excel, Visio, etc.)
* Experience working in cellular therapeutics and/or biologics manufacturing environment.
* Experience generating GMP documents (SOPs, reports, specifications, etc.)
Our Commitment to Diversity
We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at ********************* or by calling ************.
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