• Process Engineer I-II

    Job ID
    14549
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Manufacturing
  • Overview

    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. 

     

    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. 

    Responsibilities

    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
    • Implement cross-functional continuous improvement initiatives
    • Provide training and guidance for Process Engineer I 

    Qualifications

    Process Engineer I 

    Requirements 

    • BS in Biological Science or Engineering, or relevant experience in biologics manufacturing and/or cellular therapeutics processing
    • 1-year postgraduate experience related to process development and/or cGMP manufacturing within a biotech production facility
    • Knowledge in relevant math, science, and engineering disciplines
    • Working knowledge of equipment and technology as it applies to job function
    • Experience working in a regulated (GxP) environment, including a thorough understanding of GMP record keeping and documentation processes
    • Strong technical writing skills, experience creating and revising SOPs and batch records
    • Solid 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.
    • Experience with Microsoft Office Software (Word, Excel, Visio, Project, PowerPoint, etc.)
    • Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all required Personal Protective Equipment (PPE).
    • Occasional weekend and evening work required. 

      

    Preferred 

    • Experience working as a customer service provider in support of Manufacturing.
    • Experience working in a cell therapy manufacturing environment.
    • Familiarity with Process Transfer work flows, tools, and deliverables.
    • Familiarity with use of typical cell therapy production equipment; BSCs, incubators, centrifuges, etc.
    • Experience creating equipment SOPs for GMP clinical process equipment and other GMP Documents (reports, user requirement specifications, engineering studies).
    • Experience in assembling and reporting out production run summary data 

     

    Process Engineer II 

    Requirements 

    • Process Engineer II will have all the minimum and preferred qualifications of Process Engineer I in addition to the following:
    • 2-3 years of postgraduate experience related to process development and/or cGMP manufacturing within a biotech production facility
    • Advanced knowledge of GMP requirements as it applies to job function
    • Demonstrated ability to effectively manage multiple tasks/projects utilizing organization and prioritization skills
    • Experience executing Failure Mode Effects Analysis (FMEA).
    • Experience in utilizing Root Cause Analysis for Investigational purposes
    • Demonstrated capability in completing continuous process improvement projects 

     

    Preferred 

    • Familiarity with various cell therapy production process equipment such as CliniMACS, Prodigy, Lovo, Xuri, etc.)
    • Familiarity with equipment procurement and on-boarding 

    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 escmail@fredhutch.org or by calling 206-667-4700.

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