Process Engineer 1/2 (Equipment Qualification)

Research & Development
Menlo Park, CA

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GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.

GRAIL is using the power of high-intensity sequencing,population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology and to develop and commercialize pioneering products for the early detection of cancer.

We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to alleviate the global burden of cancer.

In search of the right opportunity for you? Apply to GRAIL to be considered for future roles!


Process Engineer 1/2 (Equipment Qualification)

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com

As a Process Engineer 1/2 at GRAIL, you will support development projects by contributing to a dynamic Product Development team. The ideal candidate will possess extensive experience developing manufacturing processes applicable to a high-throughput production or molecular testing environment, including evaluating and characterizing equipment and reagents, designing and testing manufacturing processes, and drafting documentation including protocols, reports and operating instructions. Candidates should possess strong troubleshooting skills and be a team player.

You Will:

  • Design and characterize new laboratory equipment qualification processes within an NGS setting. 
  • Participate in the development of product plans, evaluation of processes and process risk, and development of project timelines.
  • Develop and execute qualification studies for new and existing equipment in accordance with ISO standards.
  • Contribute to the planning, preparation, and execution of experiments to support development of the next generation of GRAIL technology.  
  • Develop strategies for characterization of automated processes, including determination of critical process parameters, control limits, and SPC rulesets.  
  • Sustain existing platforms through continuous improvement efforts, failure analysis, and maintenance of supporting documentation.
  • Support the transfer and execution of equipment qualification protocols at CMOs.  
  • Troubleshoot procedures and recommend improvements or alternative procedures if needed.
  • Responsible for accurately recording work performed per GLP, including results and methodology.
  • Calculate, compile and analyze experimental data.
  • Ensure laboratory activities are performed in compliance with procedures and safety guidelines when handling, storing, and disposing of hazardous or biohazardous materials.
  • Write reports, work instructions, and SOPs for development and transfer activities.
  • Present data at technical meetings.

Your Background Will Include:

  • B.S. in biochemistry, molecular biology, bioengineering, or related fields preferred. M.S. is a plus.
  •  1 - 4+ years of experience in the medical device or pharmaceutical industry working in process engineering, R&D, or systems engineering. 
  • Demonstrated success in technical proficiency, creativity and collaboration with others. Experience in design of studies for the evaluation and qualification of NGS-related equipment in a regulated environment is desired.
  • Experience with product development including process validation, equipment qualification (IQ/OQ/PQ), tech transfer, and process characterization required.
  • Must have excellent personal task management skills and a high level of self-motivation.
  • Expertise in molecular biology.
  • Experience with nucleic acid extraction technologies.
  • Experience with Design of Experiment methodology.
  • Experience with Six Sigma, CIP, Root Cause Analysis techniques.
  • Experience with medical device regulatory requirements and ISO quality standards.
  • Experience with automated laboratory equipment such as robotic liquid handlers and qPCR instruments.
  • Theoretical and practical knowledge of Next Generation Sequencing sample preparation workflows and applications preferred.
  • Excellent verbal and written communication skills and willingness to collaborate cross-functionally.

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We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.