Therapeutic Products Program- Process Engineer I-II
Fred Hutchinson Cancer Research Center
Location: Seattle, Washington
Internal Number: 22770
Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch's global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
TPP (Therapeutic Products Program) is a GMP manufacturing organization within the Fred Hutchinson Cancer Center that executes process operations in the production of biologics in the Biologics Production Facility and modified cellular products in the Cell Processing Facility. The Process Engineering functions within the TPP is responsible for Process Transfer from Process Development to the manufacturing group.
Process Engineer I
Serve as primary author of GMP Manufacturing Batch Records and Validation Protocols and Reports, ensuring Process accuracy and GMP Compliance
Serve as Subject Matter Expert (SME) for Manufacturing during the execution of Engineering Production Runs
Conduct process specific training for MFG Operators prior to Engineering Run execution
Ensure Manufacturing Readiness for TPP Engineering Runs
Support execution of engineering runs in preparation for clinical operations
Plan and execute validation protocols
Provide MFG data and process summaries to stakeholders following completion of production runs
Process and implement feedback on GMP manufacturing batch records and GMP documentation
Write and Revise MFG SOPs
Implement continuous improvement Process Engineering projects
Work within Quality Assurance (QA) document management systems
On-board and qualify (IQ/OQ/PQ) GMP manufacturing equipment
Provide support to quality system deliverables such as Deviation, CAPA, Change Management
Provide support for investigations into Validation and 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 and validation 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
Process Engineer I
Experience working as a customer service provider in support of MFG
Experience working in a biotechnology manufacturing environment
Familiarity with Process Transfer work flows, tools and deliverables
Familiarity with use of typical biotechnology equipment; BSCs, incubators, centrifuges, etc.
Experience creating equipment SOPs for GMP clinical process equipment, and other GMP documents (reports, user requirements, etc.)
Experience in assembling and reporting out production run summary data
Process Engineer II
Familiarity with various biotechnology process equipment such as Clinimacs, Prodigy, LOVO, KrosFlow, and chromatography columns
Familiarity with equipment procurement and on-boarding
Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 email@example.com or by calling 206-667-4700.
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.