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  • Supervisor, Engineering Operations (2nd Shift…

    GRAIL (Durham, NC)



    Apply Now

    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 Supervisor, Tier 2 Engineering Operations, supporting laboratory operations by leading a team of junior engineers in providing timely technical support and maintenance of automation systems, software tools, and lab instrumentation. This role ensures equipment reliability, system uptime, and adherence to quality and safety standards through hands-on troubleshooting, escalation management, and coordination with other technical teams. The ideal candidate has strong technical skills, attention to detail, and experience working in a regulated operations or diagnostics environment.

     

    The onsite role requires 4 days a week in Durham, NC (RTP Site)

     

    This is a full time position working in our lab 2nd Shift - Wed, Thurs, Fri, Sat 1:30 PM - 12:00 AM EST

     

    The working hours could be temporarily adjusted due to training, travel, and other events or permanently adjusted based on business needs.

     

    This position requires on-call duty and may need to support weekends and holidays.

    Responsibilities:

    + **Leadership & Team Management**

    + Supervise day-to-day activities of Tier 2 support staff across second-shift operations.

    + Train, mentor, and coach junior engineers on both technical troubleshooting and compliance-driven regulatory practices (GLP and GMP).

    + Foster a culture of **safety, accountability, continous leanring, continous improvments, and regulatory discipline** .

    + **Technical Operations & Troubleshooting**

    + Provide hands-on support for laboratory/manufacturing instrumentation, automation platforms, and software systems (e.g., liquid handlers, NGS platforms, control software).

    + Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with **QMS and FDA expectations** .

    + Oversee incident triage, root cause analysis, CAPA, and track metrics (recurrence rate, closure time).

    + **Regulatory & Change Management**

    + Lead the Engineering Operations team through the transition from **LDT to FDA-regulated IVD environment** , ensuring compliance with **21 CFR Part 820, ISO 13485, and Part 11** requirements.

    + Establish and enforce **formal change control processes** for equipment modifications, repairs, and software updates.

    + Collaborate with Quality and Regulatory Affairs to validate equipment (IQ/OQ/PQ) and document all maintenance and service activities in a compliant manner.

    + Support **FDA inspections, audits, and internal quality reviews** by ensuring readiness of maintenance, calibration, and service records.

    + **Continuous Improvement & Cross-Functional Collaboration**

    + Identify and implement process improvements to optimize lab automation performance and uptime.

    + Partner with R&D, Software, and Quality teams on system changes, new equipment validation, and controlled rollouts.

    + Ensure vendor service activities are integrated into the QMS and supplier qualification processes.

    Preferred Qualifications:

    + 4+ years of technical experience in engineering operations, automation support, or laboratory systems with BS/BA in Engineering, Life Sciences, or related field (or equivalent).

    + 1+ years in a **lead or supervisory role** , with proven ability to train and mentor junior staff.

    + Hands-on troubleshooting and repair of **lab/manufacturing automation and sequencing systems** (Hamilton, Tecan, Illumina, etc.).

    + Familiarity with **preventive maintenance, CMMS, EAM, calibration, and documentation** practices in regulated environments (cGMP/GLP, CAP, CLIA).

    + Strong communication skills and ability to lead in a **cross-functional, fast-paced environment** .

    + Willingness to work on-call and support weekends/holidays.

    + **Highly Preferred**

    + Experience with **NGS workflows and Illumina sequencing platforms** .

    + Experience with **Lean Manufacturing, 6-Sigma, equipment design and improvements.**

    + Knowledge of **EAM/CMMS systems** (Hexagon EAM preferred), LIMS, MES, and automation control software (e.g., Green Button Go).

    + Background in **change control, CAPA, and equipment validation (IQ/OQ/PQ)** .

    + Experience guiding a team or organization through a **regulatory transition** (e.g., LDT to FDA-approved IVD, ISO 13485 implementation).

    + Basic understanding of **IT infrastructure and equipment networking** .

    Physical Demands and Working Environment:

    + Onsite, laboratory/manufacturing-based role requiring standing, walking, crouching, and PPE use.

    + Must frequently lift and/or move up to 25 pounds; occasionally up to 50 pounds.

    + Hours and days may vary depending on operational need

    + Travel up to 10%.

     

    Expected full time annual base payscale for this position is $91K -$114K. 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 (https://grail.com/about/#contact-us) to request accommodation. GRAIL maintains a drug-free workplace.

     


    Apply Now



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