Validation Engineer - Qualification #3141 (Contract)
Raleigh, NC; Durham, NC
Research & Development – Lab Operations /
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.
The Sr Equipment Engineer - Qualification will coordinate, manage tasks, mentor talent, and provide technical engineering support for a variety of assets. They will primarily interact with operations, development scientists, and software engineers to ensure qualified status of our very complex operation. This includes both supporting day to day qualification execution and problem solving of inevitable issues that arise, and working to continuously improve our systems, but helping gather requirements and prioritize improvements. GRAIL’s testing volumes are scaling fast and require a dynamic and detail oriented engineer to help deliver our revolutionary test to as many people as possible.
There are multiple positions for this job. Expected schedule is Monday to Friday with a first shift start time of 8am and a second shift start time of 4pm with potential for minor changes in hours. This position may need to support weekends and holidays.
- Develop, perform, planned, and lead qualifications and associated processes to onboard, replace, modify, upgrade, and replace assets to support the area following cGMP/GLP and Quality Management System (QMS) guidelines
- Execute and document equipment lifecycle related activities (installations, calibration, maintenance, qualifications, decommissions, etc) by supporting and maintaining equipment records in our asset management and quality management systems for traceability purposes and to assure compliance with CLIA/CAP, FDA 21 CFR part 820, ISO 15189, ISO 13485, and other requirements
- Create, update, and review procedures, work instructions, guidelines, and testing documents such as installation / operational / performance qualification (IOPQ), site acceptance test (SAT), verifications, standard operating procedures (SOP)
- Work closely with Quality and regulatory to implement and follow the required policies and procedures for asset qualification, calibration, and maintenance
- Coordinate resources to support qualifications, installations, calibrations, investigations, upgrades, and/or repairs as needed
- Lead root cause investigations, drive for resolutions, and follow those up with corrective and preventative actions
- Support the investigations and act as a subject matter expert in NCRs, CAPAs, and associated quality and technical investigations
- Provide technical training, support in the creation of new training, and transfer knowledge to fellow engineers and operators. Coach and guide junior level staff
- Provide guidance and priorities to implement process optimization to improve efficiency and robustness
- Work together with development and software for successful technology transfer and further workflow improvements
- Support engineering needs of operations group
- Stay abreast of technological advances that can be implemented to drive process improvement, throughput, and cost
- Participate, be a role model, and adhere to GRAIL’s policies and guidelines
Your Background Should Include;
- 5 - 8+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience
- Demonstrated ability to successfully train, coach, and mentor junior level engineers
- Excellent verbal and written communication skills
- Excellent time management skills to support a fast paced working environment
- Excellent troubleshooting and root cause analysis skills in both hardware and software
- Strong experience with writing and implementing test protocols and procedures
- Strong industrial electrical and mechanical knowledge
- Knowledge of IT networking and systems infrastructure
- Experience working in a clinical laboratory regulated environment
- Knowledge Safety Training, lock out tag out (LOTO), Hazardous material, and waste handling
- Hands-on experience qualifying equipment in a high throughput clinical laboratory operation
- Experience executing within a computerized maintenance/calibration management system
- Strong experience qualifying liquid handling equipment. (e.g., Agilent, Hamilton, Beckman, Illumina, Dynamic Devices, etc.)
- Experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems(MES), scheduling software, Customer Relationship Management (CRM) software
- Knowledge of molecular biology to best support equipment activities in an next generation sequencing (NGS) workflow.
- Project management skills
- Experience working with Green Button Go (GBG)
- Experience working with Illumina NGS technology platforms
Physical Demands/Working Environment;
- Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear
- Must regularly lift and / or move up to 10 pounds
- Frequently lift and/or move up to 25 pounds
- Occasionally lift and/or move up to 50 pounds
- Travel up to 10% of the time
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.
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 Office and Affirmative Action 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.