Grail
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24 days ago
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 Staff Systems Engineer for the Engineering Operations team. As a Staff Systems Engineer, you will provide site-wide support for clinical and non-clinical operations activities while implementing global solutions aligned with GRAIL’s business goals. Responsibilities will include aspects of GRAILs software and asset lifecycle programs involving technical engineering support for a variety of process automation hardware, software applications, and laboratory instruments. An ideal candidate will be experienced in liquid handling and next-generation sequencing platforms, distributed environments, software integration and validation, project management, and establishing support processes in accordance with regulatory compliance guidelines. This position will be working in close collaboration with the clinical and non-clinical lab staff and multi-functional teams. Strong interpersonal and troubleshooting skills are essential for success in this position.
This is a full time, onsite position working in the Research Triangle Park, NC lab.
1st Shift Start Time: 8:00am EST - Monday to Friday
Work on holidays may be required
On-call will be required
Working hours may be temporarily adjusted due to business demands, training, travel, and other events.
Responsibilities:
- Diagnose and resolve issues with laboratory systems and equipment integrated into distributed environments, ensuring minimal downtime and optimal performance.
- Lead implementation of programs and workflow systems to support complex automated processes in a clinically regulated environment
- Collaborate with cross-functional teams to address connectivity, data synchronization, and system compatibility challenges between distributed devices and platforms.
- Reduce and improve unplanned maintenance wherever feasible. Prolong the economic life of assets at the lowest practical cost.
- Develop automated engineering solutions to resolve/mitigate repetitive failures that adversely affect plant availability, performance, capacity, quality, cost, or regulatory compliance.
- Develop & update comprehensive documentation such as qualification protocols, standard operating procedures (SOP), Work Instructions (WI), How-To-Articles, and Troubleshooting Guides
- Facilitate knowledge-sharing initiatives to improve team proficiency and reduce dependency on individual expertise
- Execute Equipment Lifecycle Management processes and procedures by supporting and maintaining equipment records for traceability purposes in compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 / 15189 requirements, and the GRAIL QMS (Quality Management System)
- Support the investigations in NCRs, CAPAs, and associated quality and technical investigations
Preferred Qualifications:
- 8+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience.
- 8+ years experience troubleshooting and maintaining laboratory equipment in distributed or networked environments
- 8+ years experience writing scripts for equipment automation tools, log analysis, and/or system monitoring (PowerShell, Python, etc…) in windows based environments. Familiarity utilizing scripting for API interactions, data parsing, and troubleshooting distributed systems.
- 8+ years experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems (MES), Customer Relationship Management (CRM) software
- 5+ years experience with real-time, process optimization automated laboratory scheduling software
- 5+ years experience with data analysis techniques including statistical process control, OEE, reliability modeling and prediction, RCA techniques, and/or six sigma methodology
- 5+ years experience using an asset computerized maintenance management system (CMMS)
- 5+ years experience maintaining low volume automated liquid handling systems (e.g. MultiFlo/Bravo, STAR/STARlet, Echo, Lynx, Lunatic, high throughput NGS sequencers)
- 5+ years experience with remote equipment access and control tools to support troubleshooting across geographically dispersed environments
- 5+ years experience project management
- 5+ years experience with an Open Source code repository and collaborative software development platform (Gitlab)
- 5+ years experience with LIMS, open source code repository, and automated laboratory scheduling applications
- Ability to work independently and as part of a team
Physical Demands and Working Environment
- Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear.
- Hours and days may vary depending on operational needs.
- Working with dry ice may be necessary.
- 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.
- Must occasionally lift and / or move up to 10 pounds.
- Must occasionally lift and/or move up to 25 pounds.
- Must occasionally lift and/or move up to 50 pounds.
- Travel may be required, up to 10% of the time.
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.