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Process Engineer 2, Assay R&D # 4457
Process Engineer 2, Assay R&D # 4457GRAIL • Durham, NC, US
Process Engineer 2, Assay R&D # 4457

Process Engineer 2, Assay R&D # 4457

GRAIL • Durham, NC, US
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Job Description

Job Description

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 Process Engineer 2, to join its R&D team in Research Triangle Park (RTP), NC to help develop and transfer a high throughput DNA processing assay for a Laboratory Developed Test. In this position, the candidate will work closely with Operations, Equipment, Facilities, Automation, and Software teams as we develop operational and maintenance processes and procedures for a groundbreaking, high-throughput automated laboratory. Candidates would ideally have hands-on experience in process development, troubleshooting and documentation within a regulated environment.

This position works on-site full-time at our facility located in Durham, NC.

Responsibilities :

  • Explore our state-of-the-art sample processing platform and develop the necessary loading, usage, and maintenance procedures to support the system for continuous operation
  • 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
  • Work within multi-functional teams to transfer processes and equipment from Research and Development into Laboratory and Operations teams.
  • Support troubleshooting efforts during integration testing
  • Off-shift or weekend coverage may occasionally be required to support the technical team during development and validation

Required Qualifications :

  • BS in an Engineering or Life Sciences Field, Chemical or Biomedical Engineering preferred
  • 3+ years manufacturing, operational development or process support experience
  • Demonstrated success writing and executing SOP’s, Work Instructions, and Test Protocols
  • Experience creating and interpreting process and material flow diagrams
  • Experience with transferring prototypes and concepts from R&D into operational environments
  • Possesses applied knowledge of failure mode analysis and troubleshooting techniques
  • Good communication skills to work independently and provide internal customer support.
  • Excellent time management skills to support a fast paced working environment.
  • Ability to take initiative and drive projects to completion with detailed and efficient execution and reporting
  • Adaptability in a frequently-changing environment
  • Demonstrate ability to work effectively as part of a cross functional team.
  • Excellent attention to detail and accuracy
  • Ability to work onsite at RTP, NC facility
  • 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.
  • Preferred Qualifications :

  • Experience working in a clinically regulated environment is highly preferred [GMP, CAP / CLIA,FDA 21 CFR Part 820, and ISO 13485]
  • Experience writing and executing qualification procedures for laboratory equipment
  • Excellent technical troubleshooting skills and mechanical proficiency
  • Experience operating liquid handling robots and other laboratory automation tools is a plus
  • Familiarity with CAD and SolidWorks
  • Physical Demands and Environment

  • May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation (Generally laboratory and customer service employees only)
  • Regularly required to stand, sit, walk, climb stairs / ladders, kneel, crouch, or wear safety gear.
  • Occasionally lift and / or move up to 50 pounds.
  • Travel up to 10%
  • The expected, full-time, annual base pay scale for this position is $82K - $97K. 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 competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies.

    GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to : recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace.

    Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified 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 at rc@grailbio.com if you require an accommodation to apply for an open position.

    For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

    We welcome job-seekers from all backgrounds to join us!

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