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 the Global Development & Operations department 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 Assay Development, Reagent Development, Operations, Equipment, and Software teams as we develop operational and maintenance procedures and processes for a groundbreaking, high-throughput laboratory. Candidates would ideally have hands-on experience in process development and documentation within a regulated environment.

This is an on-site role and requires you to be onsite 5 days a week in Menlo Park, CA 

Responsibilities:

• Assist in building out our state-of-the-art sample processing platform and develop the necessary loading, usage, and maintenance procedures to support the system for continuous operation
• Collaborate with Development teams in evaluating early-stage products and processes
• Analyze data from various sources to update platform capacity models and simulate system throughput
• Help the team balance operator efficiency, cost of goods, and maximize system uptime while upholding safety and compliance standards
• Develop and maintain user manuals, process flow charts, Standard Operating Procedures (SOPs), and work instructions around your developed methods
• Gather Critical Process Parameters (CCPs) and Critical Quality Attributes (CQAs) to support the development of equipment for GRAILs new companion and pharmaceutical diagnostics products
• Work within multi-functional teams to transfer processes and equipment from Research and Development into Laboratory and Operations teams
• Collaborate with other departments to define GRAILs assay specifications, drive equipment requirements, and develop test methods for asset qualification
• Provide technical support during integration testing and contribute to troubleshooting efforts
• Occasionally provide off-shift or weekend coverage to support technical team activities during development and validation phases

Preferred Qualifications:

• BS (MS preferred) in an Engineering or Life Sciences Field
• 3+ years of experience in manufacturing operational development, or support
• Proven track record in writing and executing SOP’s, Work Instructions, and Test Protocols
• Experience in creating and interpreting process and material flow diagrams
• Familiarity with transferring prototypes and concepts from R&D into operational environments
• Expertise in manufacturing or automation of clinical diagnostics, medical devices, or equivalent technologies
• Strong background in liquid handling equipment such as Agilent, Hamilton, Beckman, Dynamic Devices, etc.
• Knowledge of molecular biology to support equipment activities in a Next-Generation Sequencing (NGS) workflowHands-on experience in qualifying equipment within a high-throughput clinical laboratory setting
• Applied knowledge of root cause analysis and troubleshooting techniques
• Experience supporting commercial products and working cross-functionally across departments to capture system requirements and specifications 
• Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting
• Willingness to travel up to 10% of the time to our facility in North Carolina

Physical Demands and Working Environment

• Hours and days may vary depending on operational needs.
• 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 estimated, full-time, annual base pay scale for this position is $90,000 - $107,000. 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 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.