Senior/Staff Equipment Service Engineer (Liquid Handling)
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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.
As a Senior/Staff Equipment Engineer, you will provide site-wide support for clinical operations activities. Responsibilities will include the installation, maintenance, and performance of ground breaking laboratory equipment along with documenting activities in accordance with regulatory compliance guidelines. This individual will be supporting laboratory equipment that will range widely, but will include next-generation sequencing platforms and automated liquid handling robots. This position will be encouraged to work in close collaboration with the clinical lab staff and multi-functional teams. Strong interpersonal and troubleshooting skills are critical for success in this position.
You Will:
- Manage Equipment Lifecycle Management processes and procedures by supporting and maintaining equipment records for traceability purposes
- Author and maintain technical documents, including Standard Operating Procedures (SOPs), Equipment Qualification, and Maintenance Forms
- Contribute/Collaborate as a Subject Matter Expert (SME) for supporting equipment processes, while aligning with multi-functional teams (Quality Assurance (QA), Process Engineering (PE), Systems Engineering (SE), and Laboratory Operations teams
- Manage and maintain Asset Management System to support internal Equipment Program processes and procedures including calibration program
- Train operators on equipment operation and maintenance procedures
- Respond and solve equipment related issues in a timely manner
- Coordinate schedules between clinical laboratory and equipment vendors/suppliers on planned and unplanned maintenance activities to minimize downtime
- Work with facilities team to ensure site requirements are met before installation of new equipment
- Serve as a primary point of contact for hosting vendor IQ, OQ, calibration, PM, and/or repairs with minimal supervision
- Ensure that all work performed by external contractors is completed and documented in accordance with the site Quality Management System (QMS)
- Configure, manage, and respond to wireless temperature monitoring system alert notifications for cold storages and laboratory temperature/humidity
- Maintain lab equipment in good working order following cGMP/GLP and Quality Management System (QMS) guidelines
- Document all equipment related activities to assure compliance with CLIA/CAP and ISO 13485 requirements
Your Background Should Include:
- BS/BA or equivalent in Engineering, Physics, Chemistry or Life Sciences
- 5+ years of experience working on laboratory equipment
- Mange, mentor, and provide guidance to junior level engineers and technicians, as an opportunity to build and lead a team
- Excellent time management skills to support fast pace working environment
- Good communication skills to work independently and provide internal customer support
- Hands-on experience supporting in high throughput, sample processing laboratories supporting operations and scale activities
- Experience working in a regulated manufacturing environment; medical device, pharmaceutical, under ISO and/or FDA Regulations
- Experience with calibration program; establishing requirements, database management, out-of-tolerance conditions, and change control
- Experience working in a clinically regulated environment is highly desirable
- Prior history working with Illumina NGS technology platforms and/or automated liquid handlers
- Excellent technical troubleshooting skills and mechanical aptitude
- Basic knowledge of molecular biology to best support equipment activities
- Basic knowledge of IT networking and systems infrastructure
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies (“Agency”), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings (“Agreement”). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team.