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Equipment Validation Engineer II - 2637

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.

Grail is seeking a Validation Engineer II to join its R&D team in RTP, North Carolina. We are building a high throughput, highly automated testing platform and need validation engineers to demonstrate that the equipment and subsystems are fit for intended use. In this position, the candidate will work closely with Assay, Automation, Software, Quality, and Operations teams to develop the qualification and commissioning documentation for equipment in our medical device manufacturing and testing facility. Candidates should be comfortable operating and testing a wide range of laboratory equipment of varying complexity and customization. Must have prior experience authoring Installation, Operational, and Performance Qualifications in a regulated manufacturing environment

The Successful Candidate Will:

Support the design of qualification plans and reports to qualify equipment for the manufacture and inspection of a medical device for the early detection of cancer
Support the design of qualification plans and reports to qualify equipment used in a highly automated, high throughput testing laboratory for sequencing of DNA in human samples
Translate User Needs, System Requirements, and Assay Tolerances into technical specifications/user requirement specifications
Author, update, and maintain user requirements, functional specifications, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, decommissioning plans and other qualification deliverables as required by the site equipment lifecycle and qualification SOPs.
Partner with the System Owners, Quality System Administrators, and Equipment and Process Engineers to drive consensus and meet qualification deadlines
Ensure lab instrument’s adherence to regulatory guidelines, as necessary, to cGMP, ISO 13485, FDA 21 CFR Part 11, CLIA and CAP. For systems found unable to fully comply, formulate workarounds/strategies with core stakeholders to mitigate the gaps.
Complete periodic reviews of laboratory instruments and associated instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.
Train engineering teams to properly execute your qualification protocols
Review validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed

Must Have:

BS in an Engineering or Life Sciences Discipline
3+ years of manufacturing or laboratory systems qualification
Significant experience translating user needs and design inputs into instrument and equipment installation and operational qualification protocols
Knowledge of FDA Regulations/Guidance for Medical Device Manufacturing and/or Good Manufacturing Practices
Demonstrated statistical analysis skills in order to justify sample size selection and summarize output data
Ability to manage multiple activities and constantly change priorities
Proficient in the use and operation of a variety of manufacturing, inspection, and laboratory instruments
Ability to work both independently and in partnership with others
Proven ability to use initiative and drive to achieve results
Experience transferring concepts and documentation from R&D into operational and technical teams
Excellent communication skills, oral and written, and attention to detail
Strong critical thinking and problem-solving skills

Preferred Skills:

Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11
Experience working in a clinically regulated environment is highly preferred
Familiarity with lab automation and automated instrumentation
Basic knowledge of molecular biology and Next-Gen DNA Sequencing to support equipment activities
Ability to drive processes around root cause analysis and troubleshooting techniques

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.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.

GRAIL Glassdoor Company Review

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