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 Sr. Validation Engineer to join its R&D team in RTP, North Carolina. In this position, the candidate will work closely with Assay, Automation, Software, and Operations teams to develop the qualification framework, plans, and protocols for equipment used in both a PMA and LDT environment. Candidates should have strong hands-on experience with process development, IQ/OQ/PQ, and documentation to a cGMP, GCLP, and/or CAP/CLIA standard. You Will:
Your Background Should Include:
- Serve as validation lead for laboratory instruments on a highly automated, high throughput clinical assay.
- Translate User Needs, System Requirements, and assay tolerances into technical specifications.
- Partner with the Clinical Lab Managers, Quality System Administrators, and Equipment and Process Engineers to qualify new instruments at the site.
- Author and Maintain the Equipment Qualification Master Plan to define validation strategy for laboratory equipment used within a regulated diagnostic test.
- Initiate and lead risk assessments, gap analysis, and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Control laboratories.
- Author cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs.
- Ensure lab instrument’s adherence to regulatory guidelines, as necessary, to cGMP, FDA 21 CFR Part 11, CLIA and CAP.
- Author protocols to challenge the main aspects of these requirements during validation to demonstrate adherence.
- For systems found unable to fully comply, formulate workarounds/strategies with core stakeholders to mitigate the gaps.
- Assist the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans.
- Complete periodic reviews of laboratory instruments (production and R&D) and associated instrument control software with focus on change control, deviation investigations and CAPA to ensure compliance and validated state of the instrument. Identify and consult with Operations Team stakeholders to integrate qualification procedures into the framework for existing work streams.
- Analyze data from multiple sources and help the team balance operator efficiency, cost of goods, and system uptime while maintaining a safe and compliant work environment.
- Write and maintain user manuals, process flow charts, SOP’s, and work instructions around your developed methods.
- Review validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.
- May supervise and/or mentor junior level engineers.
Preferred Education & Experience:
- A Bachelor's Degree in an Engineering or Life Sciences Discipline.
- A minimum of five (5) years of delivering qualified equipment into a manufacturing or production environment.
- Significant experience translating user needs and design inputs into instrument qualification protocols.
- Proficient knowledge of FDA Regulations/Guidance, Good Manufacturing Practices (ISO 13485), and Medical Device validation/qualification requirements.
- Demonstrated statistical analysis skills in order to collate data for and assign values to parameter specifications Ability to manage multiple activities and constantly change priorities.
- Familiarity with lab operations, processes, and a variety of laboratory instruments within Biological, Chemical, Environmental Monitoring, or similar areas.
- 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 environments.
- Excellent communication skills, oral and written, and attention to detail Strong critical thinking and problem-solving skills.
- A Master’s Degree/PhD in an Engineering or Life Sciences Discipline.
- A minimum of three (3) years of experience delivering qualified equipment into a manufacturing or production environment.
- Familiarity with LDT requirements for equipment and their differences from cGMP.
- Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11.
GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. 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
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.