Process Engineer II # 2764

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 Process Engineer II to join its R&D team in Menlo Park, CA to transfer a high throughput DNA processing assay for a Laboratory Developed Test. In this position, the candidate will work closely with Development, Operations, Equipment, Facilities, and Software teams as we develop operational and maintenance procedures for a groundbreaking, high-throughput laboratory. Candidates would ideally have hands-on experience in process development and documentation within a regulated environment.
You will:

• Drive new and next generation products in the Grail pipeline through mid to late stage development.
• Virtually support our state-of-the-art sample processing platform and develop the necessary loading, usage, and maintenance procedures to support the system for continuous early stage development.
• 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, standard operating procedures (SOP’s), and work instructions around your developed methods
• Create Test Protocols including installation / operational / performance qualification (IOPQ), characterization studies, verifications, and validations.
• Work within multi-functional teams to transfer processes and equipment from Research and Development into Laboratory and Operations teams.
• Off-shift or weekend coverage may occasionally be required to support the technical team during development and validation

Your background and qualifications will include:

• BS (MS preferred) in an Engineering or Life Sciences Field
• 3+ years manufacturing or operational development or support experience
• Demonstrated success writing and executing SOP’s, Work Instructions,Test Protocols and, Testing Method Development
• Experience creating and interpreting process and material flow diagrams
• Experience with transferring prototypes and concepts from R&D into operational environments
• Possesses applied knowledge of root cause analysis and troubleshooting techniques
• Experience in supporting customer-facing products
• Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting
• Ability to work from Menlo Park, CA facility

Preferred Skills:

• Experience working in a regulated environment is high preferred [cGMP, CLIA/CAP, FDA 21 CFR part 820, ISO 15189, ISO 13485]
• Experience writing qualification procedures for laboratory equipment
• Familiarity with molecular biology tools and techniques to support equipment activities
• Excellent technical troubleshooting skills and mechanical proficiency
• Experience operating liquid handling robots and other laboratory automation tools is a plus
• Familiarity with next generation sequencing (NGS) technology.

Physical Environment and Travel

• Must be able to travel 10% of the time to the NC facility
• Standing or sitting for long periods of time may be necessary.
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation.

The expected, full-time, annual base pay scale for this position is $88,000 - $104,000
Actual base pay will consider skills, experience, and location.

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

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. GRAIL maintains a drug-free workplace.