Process Engineer 2, Assay R&D # 4457

Grail • Durham, NC

1d • Onsite

About The Position

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com . Grail is seeking a Process Engineer 2, to join its R&D team in Research Triangle Park (RTP), NC to help develop and transfer a high throughput DNA processing assay for a Laboratory Developed Test. In this position, the candidate will work closely with Operations, Equipment, Facilities, Automation, and Software teams as we develop operational and maintenance processes and procedures for a groundbreaking, high-throughput automated laboratory. Candidates would ideally have hands-on experience in process development, troubleshooting and documentation within a regulated environment. This position works on-site full-time at our facility located in Durham, NC.

Requirements

• BS in an Engineering or Life Sciences Field, Chemical or Biomedical Engineering preferred
• 3+ years manufacturing, operational development or process support experience
• Demonstrated success writing and executing SOP’s, Work Instructions, and Test Protocols
• 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 failure mode analysis and troubleshooting techniques
• Good communication skills to work independently and provide internal customer support.
• Excellent time management skills to support a fast paced working environment.
• Ability to take initiative and drive projects to completion with detailed and efficient execution and reporting
• Adaptability in a frequently-changing environment
• Demonstrate ability to work effectively as part of a cross functional team.
• Excellent attention to detail and accuracy
• Ability to work onsite at RTP, NC facility
• Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Nice To Haves

• Experience working in a clinically regulated environment is highly preferred [GMP, CAP/CLIA,FDA 21 CFR Part 820, and ISO 13485]
• Experience writing and executing qualification procedures for laboratory equipment
• Excellent technical troubleshooting skills and mechanical proficiency
• Experience operating liquid handling robots and other laboratory automation tools is a plus
• Familiarity with CAD and SolidWorks

Responsibilities

• Explore our state-of-the-art sample processing platform and develop the necessary loading, usage, and maintenance procedures to support the system for continuous operation
• 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
• Work within multi-functional teams to transfer processes and equipment from Research and Development into Laboratory and Operations teams.
• Support troubleshooting efforts during integration testing
• Off-shift or weekend coverage may occasionally be required to support the technical team during development and validation

Benefits

• 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 competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees