Validation Engineer 1 #4134

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 Validation Engineer 1 for the Engineering Operations Organization. The Validation Engineer 1 will coordinate, execute tasks, 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.

The on-site role requires 5 days a week in Durham, NC (RTP Site). This is a full time position working in our lab with a start time of 8:00 AM Monday through Friday (first shift). The working hours could be temporarily adjusted due to training, travel, and other events. This position may need to support weekends and holidays.

Responsibilities:

• Perform and plan 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, maintenance, and software validation
• Participate of the coordination of resources to support qualifications, installations, calibrations, investigations, upgrades, and/or repairs as needed
• Support root cause investigations and corrective and preventative actions
• Support the creation of new training and knowledge transfer to fellow engineers and operators.
• Support process optimization to improve efficiency and robustness
• Work together with development and software for successful technology transfer and further workflow improvements
• Participate and adhere to GRAIL’s policies and guidelines

Preferred Qualifications:

• 1+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience
• 6+ months experience with writing and implementing test protocols and procedures.
• 6+ months experience working in a clinical laboratory regulated environment.
• 6+ months experience executing within a computerized maintenance/calibration management system.
• 6+ months Hands-on experience qualifying equipment in a high throughput operation
• Good verbal and written communication skills
• Good time management skills to support a fast paced working environment
• Ability to travel up to 10% of the time

Physical Demands and Working Environment:

• Hours and days may vary depending on operational needs
• 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.
• Working with dry ice may be necessary.
• Working on confined spaces may be necessary
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.

The expected, full-time, annual base pay scale for this position is $68,000 - $80,000.  Actual base pay will consider skills, experience, and location.

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.