Overview

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.

Responsibilities

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

Qualifications

Minimum Qualifications:

• Process Engineer I
  • BS in a Biological Science or Engineering, or relevant experience in biologics manufacturing and/or cellular therapeutics processing
  • 3 years prior experience working within a Biotech production facility
  • Knowledge in relevant math, science, validation, and engineering disciplines
  • Working knowledge of equipment and technology as applies to job function
  • Experience working in a regulated (GxP) environment, including a thorough understanding of GMP record keeping and documentation practices
  • Strong technical writing skills, experience creating and revising SOPs, batch records, and validation protocols
  • 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 basic Microsoft Office Software (Word, Excel, Visio, 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
• Process Engineer II
  • Process Engineer II will have all the minimum and preferred qualification of Process Engineer I in addition to the following:
  • Advanced knowledge of GMP requirements as it applies to job function
  • Demonstrated ability to effectively manage multiple tasks/projects utilizing organization and prioritization skills
  • Strong trouble shooting and problem solving 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 Qualifications:

• 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 hrops@fredhutch.org or by calling 206-667-4700.