Validation Engineer (Tech Ops) #2167

Raleigh-Durham, NC /
Laboratory Operations /
Full-Time
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 Validation Engineer in Technical Operations in our North Carolina (RTP) facility. The ideal candidate is a great teammate with hands-on experience implementing, validating, carrying out, and solving automated molecular testing procedures and a willingness to lead and teach others. The candidate will be encouraged to think outside of the box and creatively solve problems related to the verification, validation, and execution of NGS-based workflows. They will work collaboratively across many organizational functions and implement experiments, and develop qualification and validation plans both individually and as a team. The candidate will be instrumental in documenting and resolving nonconformances, and performing in-depth investigations to support the implementation of process improvements in support of GRAIL operations.

YOU WILL:

    • Independently design and conduct experimentation, and analyze data from experiments to support several automated NGS-based assays
    • Identify SMEs and collaborate with cross-functional teams to: identify appropriate parameters and metrics, design relevant methods to execute GxP/ISO/CAP/CLIA verification and validation testing of molecular and automated liquid handling processes
    • Use productivity software (e.g. Jira, Confluence, Smartsheets) to track and report progress on verification, validation effort progress
    • Assess newly developed process improvements for verification/validation readiness, identify and address gaps
    • Lead verification and validation projects, consulting leadership for guidance on regulatory compliance and best practices as appropriate
    • Author verification/validation plans and reports in accordance with GxP/ISO/CAP/CLIA requirements
    • Summarize verification/validation results accurately and succinctly, and document appropriately within a regulatory compliant Quality Management System
    • Contribute to the design and maintenance of data collection efforts in support of process/product improvement and optimization efforts
    • Review performance data and specifications related to instrumentation, equipment, and consumables used in the execution of GRAIL’s commercial assay(s)
    • Plan and record studies and investigations performed and recorded in line with regulatory requirements (GxP/ISO/CAP/CLIA)
    • Act and present as a Technical Operations SME for equipment, equipment performance specifications, and processes related to current execution of assays executed by the Lab Operations team
    • Promptly gather, analyze, and summarize data to inform nonconformance containment activities

YOUR BACKGROUND SHOULD INCLUDE:

    • Minimum of B.Sc. / M.S. in BioEngineering, Molecular Biology, Biochemistry, or a related field with 5+ years of related experience. Job Title/Level will be based on education and demonstrated experience
    • Effective written and verbal communication skills (fluency in English) as well as strong interpersonal, negotiation, and influencing skills
    • Strong self-direction, willingness and ability to learn new techniques independently and quickly
    • Strong communication, planning, prioritization, problem-solving, and organizational skills
    • Strong technical writing skills: professional record of clear, concise, compliant record generation
    • Demonstrated experience acting in a leadership capacity on diverse and interdepartmental project teams required
    • Demonstrated record of implementing and troubleshooting automated liquid handling workflows required
    • General digital literacy and proficiency in GSuite and/or Microsoft Office Suite required
    • General proficiency in basic multivariate statistical analyses, use of statistical software (JMP, Tableau, SPS, Minitab) required
    • Proficiency with R, Python, LabWare strongly preferred
    • Automated NGS library preparation strongly preferred
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, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. 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.