Job Information
GRAIL Process Engineer II, Assay Automation #3502 in Menlo Park, California
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.
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