Senior Process Engineer - #2037

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. Process Engineer to join its R&D team in RTP, North Carolina, to transfer a high throughput DNA processing assay for a Laboratory Developed Test. In this position, the candidate will work closely with R&D, Hardware, Automation, Software, and Operations teams as we develop procedures for maintaining a groundbreaking, high-throughput laboratory. Candidates should have hands-on experience in process development and documentation within a regulated environment.
YOU WILL

• Explore our innovative sample processing platform and develop the necessary loading, usage, and maintenance procedures to support the system for continuous operation
• Identify and consult with Operations Team partners to integrate the platform into 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
• Lead or support troubleshooting efforts, including root cause analysis, to resolve issues during integration testing
• Find opportunities for process improvement 
• Balance competing deliverables within a project schedule without direct supervision
• Define, track, and report on key metrics and progress in meeting project achievements
• Occasionally support off-shift or weekend coverage to support the technical team, based on project-specific assignments

YOUR BACKGROUND WILL INCLUDE

• BS (MS/PhD preferred) in an Engineering or Life Sciences Field
• 5 - 10+ years of manufacturing or operational development or support experience
• Experience working under CAP/CLIA/cGMP/cGLP
• Experience transferring prototypes and concepts from R&D into operational environments
• Demonstrated success writing and implementing test protocols and equipment SOP’s
• Possesses applied knowledge of root cause analysis and troubleshooting techniques
• Adherence to design control practices during product development
• Experience in supporting customer-facing products
• Previous experience mentoring junior team members
• Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting
• Experience writing qualification procedures for laboratory equipment
• Ability to work from Durham, NC facility

PREFERRED SKILLS

• Experience performing risk assessments, such as failure mode and effect analysis (FMEA)
• Able to perform statistical analysis of process data to identify trends or shifts in performance
• Prior history working with Illumina NGS technology platforms is a plus
• Excellent technical troubleshooting skills and mechanical proficiency

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.