Senior Instrument Validation Engineer #3431

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 Sr. Instrument Validation Engineer to join its R&D team in RTP, North Carolina. In this position, the candidate will work closely with Assay, Automation, Software, and Operations teams to develop the qualification framework, plans, and protocols for equipment used in both a PMA and LDT environment.   Candidates should have strong hands-on experience with process development, IQ/OQ/PQ, and documentation to a cGMP, GCLP, ISO, and/or CAP/CLIA standard. This is an in-person role.

You Will:

• Serve as validation lead for laboratory instruments on a highly automated, high throughput clinical assay
• Translate User Needs, System Requirements, and assay tolerances into technical specifications
• Partner with the Clinical Lab Managers, Quality System Administrators, and Equipment and Process Engineers to qualify new instruments at the site
• Update and Maintain the Equipment Qualification Master Plan to define validation strategy for laboratory equipment and equipment subsystems used within a regulated diagnostic test
• Author cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, revisions, deviations, and other validation deliverables as required by the site validation SOPs.
• Ensure lab instrument’s adherence to regulatory guidelines, as necessary, to cGMP, FDA 21 CFR Part 11, CLIA and CAP.  Author protocols to challenge the main aspects of these requirements during validation to demonstrate adherence.  For systems found unable to fully comply, formulate workarounds/strategies with core stakeholders to mitigate the gaps.
• Complete periodic reviews of laboratory instruments (production and R&D) and associated instrument control software with focus on change control, deviation investigations and CAPA to ensure compliance and validated state of the instrument. 
• Identify and consult with Operations Team stakeholders to integrate qualification procedures into the framework for existing workstreams
• 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 environment
• Write and maintain user manuals, process flow charts, SOP’s, and work instructions around your developed methods. Train junior engineers to execute your protocols.
• Review validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed
• May supervise and/or mentor junior level engineers

Your Background Will Include:

• BS  in an Engineering or Life Sciences Discipline
• A minimum of five (5) years delivering qualified equipment into a manufacturing or production environment
• Significant experience translating user needs and design inputs into instrument qualification protocols
• Proficient knowledge of FDA Regulations/Guidance, Good Manufacturing Practices (ISO 13485), and Medical Device validation/qualification requirements
• Demonstrated statistical analysis skills in order to collate data for and assign values to parameter specifications 
• Ability to manage multiple activities and constantly change priorities
• Familiarity with lab operations, processes, and a variety of laboratory instruments within Biological, Chemical, Environmental Monitoring, or similar areas
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
• Experience transferring concepts and documentation between R&D and Operational environments
• Excellent communication skills, oral and written, and attention to detail
• Strong critical thinking and problem-solving skills

Preferred Skills 

• A Master’s Degree in an engineering or Life Sciences Discipline
• Experience operating or qualifying automated liquid handlers (Hamilton STAR, Dynamic Device LYNX) or custom robotics platforms
• Familiarity with molecular biology laboratory equipment for use in qPCR,