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Staff Process Engineer #2532

Employer
GRAIL, LLC
Location
Menlo Park, CA
Start date
Sep 23, 2022

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Job Details

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 headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

Grail is seeking a passionate and talented individual to lead the R&D Process Engineering team, with a focus on transferring products, processes, and technologies into operations, at our facility in RTP, North Carolina. In this position, the candidate will work closely with R&D, Hardware, Automation,  Software, and Operations teams as we develop procedures to  support execution of various labs and platforms, including a groundbreaking, high-throughput laboratory.   Candidates should have strong hands-on experience in process development and documentation within a cGMP, GCLP, and/or CAP/CLIA environment.
You will:
  • Shape and refine various sample processing platforms and develop the necessary loading, usage, and maintenance procedures to support the system for continuous operation
  • Bring operational strategies and concepts into development experimentation / design discussions for future scalability and robustness
  • Develop assay and reagent integration strategy and reagent formats on automated systems
  • Gather and collate characterization of critical process inputs and outputs
  • Drive risk assessments for early-stage products / processesInterface with sister site Process Engineer Team members to align processes and operational best practices
  • Analyze data from multiple sources and help the team balance operator efficiency, cost of goods, and system uptime while maintaining a safe and compliant work environmentLead or support troubleshooting efforts, including root cause analysis, to resolve issues during integration testing
  • Collaborate with development teams to identify opportunities for optimization of workflows and increased operational efficiency
  • Balance competing deliverables within a project schedule without direct supervision
  • Define, track, and report on key metrics and progress in meeting project milestones
  • Assist in troubleshooting, and automated assay and test method optimization, using engineering statistical models and uncertainty analysis
  • Draft plans, reports, work instructions, process flow charts, user manuals, and SOPs for development and transfer activities
  • Identify opportunities for process improvement, focusing on manufacturing and integration, supporting robustness and capacity
  • Ensure implementation of continuous improvement is done in compliance with change control processes
  • Participate in project planning as part of a cross-functional team
  • Ensure laboratory activities are performed in compliance with procedures and safety guidelines when handling, storing and disposing of hazardous or biohazardous materials.


Your Background Will Include:
  • Must Have BS (MS/PhD preferred) in an Engineering or Life Sciences discipline
  • 8+ years of process workflow design and development or similar experience
  • Experience in streamlining workflows and developing laboratory processes, from prototype/concept generation and R&D requirement gathering to transferring into operational environments
  • Demonstrated success writing and executing test protocols, procedural instructions, and process engineering related documents
  • Possesses applied knowledge of root cause analysis and troubleshooting techniques
  • Adherence to design control practices during product development
  • Previous experience working in matrixed and cross-functional project teams
  • Ability to work from Menlo Park, CA facility
  • Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reportingIntermediate knowledge of molecular biology to support equipment activities




Preferred Skills:
  •  Experience as a Scientist or Engineer with automated development of next-generation sequencing (NGS) assays and/or standard molecular biology techniques such as plasma isolation, DNA extraction, PCR, etc
  • Experience operating liquid handling robots and other laboratory automation tools is strongly preferred
  • Experience performing risk assessments, such as failure mode and effect analysis (FMEA)
  • Experience writing qualification procedures or process validations for laboratory equipmentExperience working in a clinically regulated environment is high preferred
  • Prior history working with Illumina NGS technology platforms is a bonus
  • Excellent technical troubleshooting skills and mechanical proficiencyProficient knowledge of molecular biology to support equipment activities

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.

Company

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 headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

LEADERSHIP:

CEO: Bob Ragusa

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Find Us
Website
Phone
833-694-2553
Location
1525 O'Brien Drive
Menlo Park
California
94025
United States
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