GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
Raleigh-Durham, NC

Validation Engineer (Tech Ops) #2168 (Raleigh, NC)

| Raleigh-Durham, NC
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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 in Technical Operations in our North Carolina (RTP) facility. The ideal candidate is a great teammate with hands-on experience implementing, validating, carrying out, and solving automated molecular testing procedures and a willingness to lead and teach others. The candidate will be encouraged to think outside of the box and creatively solve problems related to the verification, validation, and execution of NGS-based workflows. They will work collaboratively across many organizational functions and implement experiments, and develop qualification and validation plans both individually and as a team. The candidate will be instrumental in documenting and resolving nonconformances, and performing in-depth investigations to support the implementation of process improvements in support of GRAIL operations.

You Will:

  • Independently design and conduct experimentation, and analyze data from experiments to support several automated NGS-based assays
  • Identify SMEs and collaborate with cross-functional teams to: identify appropriate parameters and metrics, design relevant methods to execute GxP/ISO/CAP/CLIA verification and validation testing of molecular and automated liquid handling processes
  • Use productivity software (e.g. Jira, Confluence, Smartsheets) to track and report progress on verification, validation effort progress
  • Assess newly developed process improvements for verification/validation readiness, identify and address gaps
  • Lead verification and validation projects, consulting leadership for guidance on regulatory compliance and best practices as appropriate
  • Author verification/validation plans and reports in accordance with GxP/ISO/CAP/CLIA requirements
  • Summarize verification/validation results accurately and succinctly, and document appropriately within a regulatory compliant Quality Management System
  • Contribute to the design and maintenance of data collection efforts in support of process/product improvement and optimization efforts
  • Review performance data and specifications related to instrumentation, equipment, and consumables used in the execution of GRAIL’s commercial assay(s)
  • Plan and record studies and investigations performed and recorded in line with regulatory requirements (GxP/ISO/CAP/CLIA)
  • Act and present as a Technical Operations SME for equipment, equipment performance specifications, and processes related to current execution of assays executed by the Lab Operations team
  • Promptly gather, analyze, and summarize data to inform nonconformance containment activities

Your Background Should Include:

  • A Bachelor's of Science in BioEngineering, Molecular Biology, Biochemistry or related field.
  • A minimum of five (5) years of related experience.
  • Job Title/Level will be based on education and demonstrated experience.
  • Effective written and verbal communication skills (fluency in English) as well as strong interpersonal, negotiation, and influencing skills.
  • Strong self-direction, willingness and ability to learn new techniques independently and quickly.
  • Strong communication, planning, prioritization, problem-solving, and organizational skills.
  • Strong technical writing skills: professional record of clear, concise, compliant record generation.
  • Demonstrated experience acting in a leadership capacity on diverse and interdepartmental project teams.
  • Demonstrated record of implementing and troubleshooting automated liquid handling workflows.
  • General digital literacy and proficiency in GSuite and/or Microsoft Office Suite.
  • General proficiency in basic multivariate statistical analyses, use of statistical software (JMP, Tableau, SPS, Minitab).

Preferred Education & Experience:

  • A Master's of Science in BioEngineering, Molecular Biology, Biochemistry or related field.
  • Proficiency with R, Python, LabWare.
  • Automated NGS library preparation.

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 and “Up to Date” with any recommended booster. “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; "Up to Date" means having timely received any COVID-19 vaccine booster(s) in accordance with CDC guidelines. 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.

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What are GRAIL Perks + Benefits

GRAIL Benefits Overview

We’re committed to creating the best experience for everyone at GRAIL, ensuring that each member of our team has comprehensive benefits and resources to thrive at all stages of life, both at work and at home.

Culture
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Unconscious bias training
Diversity manifesto
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Onsite Gym
Team workouts
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Company sponsored family events
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
Free Daily Meals
Game Room
Happy Hours
Parking
Professional Development Benefits
Job Training & Conferences
Diversity Program
Cross functional training encouraged
Promote from within
Mentorship program
Online course subscriptions available

An Insider's view of GRAIL

How does your team reward individual success?

People grow their skills both by learning how to rapidly build scalable software systems, but also by partnering with scientists and other domain experts to better understand, model, and envision the systems we will need. We enable and empower our engineers to lead this process and grow with our systems as they make the future of GRAIL a reality.

Tristan Matthews

Senior Director, Software Engineering

What projects are you most excited about?

GRAIL has a unique opportunity to scale our operations to add value with our early detection test. Our automation team works on the full spectrum of projects from low-level instrument investigations to overall architectures of processing facilities. I'm excited by projects that push the boundaries of lab automation, and that's what GRAIL is doing.

David Jenions

Principal Automation Engineer

What does career growth look like on your team?

Our mission, to detect cancer early, is truly seeking a needle in many haystacks. Our lab has a very complex and sophisticated assay to execute. We leverage cross-training and mentorship programs where new teammates learn the ropes from senior staff. My team sets people up for success by turning tasks into learning opportunities.

Maryam Hosseini

Director, Laboratory Operations

How do your team's ideas influence the company's direction?

The biological problem we're trying to solve is a complex machine learning problem with human lives at stake. From a software engineering point of view, taking massive data, organizing it, building tools to mine it, and deliver results in a scalable, secure, and clinically compliant manner are areas of innovation. This, for me, is my dream job!

Satnam Alag

SVP, Software Engineering

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