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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
A Process Engineer position is immediately available in the Cell Processing Facility (CPF) within the Therapeutic Products Program (TPP) , a Fred Hutch Department supporting the development and manufacturing of novel biological molecules and innovative cell-based therapies for Phase I/II clinical Testing. CPF is a GMP manufacturing organization that executes process operations in the production of modified cellular products for patients participating in cell therapy clinical trials. The Process Engineering function within the CPF is responsible for Process and Technology transfer from CPF Process Development and external clients into the CPF Manufacturing Group.
Please note: This position may be filled as Process Engineer I or II, depending on level of experience.
Process Engineer I
Serve as primary author of GMP Manufacturing Batch Records, ensuring Process accuracy and GMP Compliance
Serve as Subject Matter Expert (SME) during the execution of Engineering Runs
Conduct process specific training for MFG Operators prior to Engineering Run execution
Ensure Manufacturing Readiness for CPF Engineering Runs
Support execution of engineering runs in preparation for clinical operations
Provide MFG data and process summaries to stakeholders following completion of engineering runs
Process and implement feedback on GMP manufacturing batch records and GMP documentation
Write and Revise site MFG SOPs
Implement continuous improvement Process Engineering projects
Work within Quality Assurance (QA) document management systems
On-board simple manufacturing equipment
Provide support to quality system deliverables such as Deviation, CAPA, Change Management
Provide support for investigations into MFG deviations
Communicate and work cross-functionally to ensure proper process transfer.
Serve as liaison between MFG and QA, QC and Process Development.
Interface and collaborate with Principal Investigators and Process Development to ensure proper manufacturability and scalability of process
Process Engineer II
Process Engineer II will be able to perform all duties of Process Engineer I in addition to the following:
Design and execute engineering study protocols
Develop and implement process Improvement opportunities
Assist in troubleshooting and problem solving to simplify and improve efficiencies within MFG
Assist in the development and utilization of tools to collect and process feedback on use of GMP documentation.
Specify complex manufacturing equipment and systems requirements
Lead teams in execution of Failure Mode Effects Analysis (FMEA)
Design, implement, and verify effectiveness of Corrective Actions
Experience in utilizing Root Cause Analysis for Investigational purposes
Demonstrated capability in completing continuous process improvement projects
Familiarity with various cell therapy production process equipment such asCliniMACS, Prodigy,Lovo,Xuri, etc.)
Familiarity with equipment procurement and on-boarding
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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.