Senior Operations Engineer - RTP - 2822
Posted on: January 25, 2023
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 .***WE STRONGLY ENCOURAGE OUR VETERAN
COMMUNITY TO APPLY***The Senior Operations Engineer will
coordinate, manage tasks, mentor talent, and provide technical
engineering support for a variety of process automation hardware,
software applications, and laboratory equipment. They will
primarily interact with clinical operations, research scientists,
and software developers to ensure smooth running of our very
complex operation system. This includes both supporting day to day
debugging 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 lead to
help deliver our revolutionary test to as many people as
possible.There are multiple positions for this job. Expected
schedule is Monday to Friday with a first shift start time of 8am
and a second shift start time of 4pm with potential for minor
changes in hours as the team expands. This position requires
on-call duty and may need to support weekends and holidays.You
- Build and manage a team of engineers with the diverse
scientific and technical skills required to support, troubleshoot
and improve complex automation systems in a regulated
- Establish a world class support team to address issues in a
timely manner and maximize the system up time for 24x7
- Provide guidance and priorities to implement process
optimization to improve efficiency, throughput and robustness.
- Establish operational objectives and work plans, delegate and
empower team members
- Oversee service contracts and CAPEX spends for operations
- Work closely with Quality and regulatory to implement and
follow the required policies and procedures for system
- Work closely with Operations team and finance on planning
equipment and resource needs for scale up to meet capacity
- Work together with R&D and software for successful
technology transfer and further workflow improvements
- Support engineering and automation needs of operations
- Stay abreast of technological advances that can be implemented
to drive process improvement, throughput, and cost
- Lead area work responsibilities, effectively triage
opportunities, direct work based on team skill set, and coach and
guide junior level staff.
- Lead and perform live troubleshooting, recovery, debugging,
repairs, and maintain equipment and systems in good working order
to support the area and operators' day to day following cGMP/GLP
and Quality Management System (QMS) guidelines.
- Lead root cause investigations, drive for resolutions, and
followthose up with corrective and preventative actions for
software and hardware opportunities.
- Be the technical lead by knowing software, processes, and
- Make time sensitive technical decisions.
- Manage spare parts inventory for area of responsibility.
- Manage, source, and coordinate vendors to support
qualifications, installations, calibrations, investigations,
upgrades, preventive maintenance (PM), and/or repairs as
- Create, update, and execute procedures, work instructions,
guidelines, and testing documents such as installation /
operational / performance qualification (IOPQ), site acceptance
test (SAT), verifications, standard operating procedures
- Execute and document all equipment lifecycle related activities
(installations, maintenance, calibration, qualifications, repairs,
etc) by supporting and maintaining equipment records in and out of
our Asset Management System for traceability purposes and to assure
compliance with CLIA/CAP, FDA 21 CFR part 820, and ISO 13485
- Provide technical training, support in the creation of new
training, and transfer knowledge to fellow engineers and laboratory
- Respond to environmental monitoring system alert notifications
for cold storages and laboratory temperature/humidity sensors for
area of responsibility.
- Participate, be a role model, and adhere to GRAIL's policies
- Recommend and implement changes to ensure ongoing high-quality
performance of laboratory equipment as part of the continuous
- Support the improvement of GRAIL's groundbreaking, fully
automated, high throughput laboratory equipment and systems and
provide expertise with solving all things automation and liquid
handling (Hamilton, Agilent, Bravos, Beckman Echo, Illumina) in
order to optimize multiple processes associated with our NGS cancer
- Support the investigations and act as a subject matter expert
in NCRs, CAPAs, and associated quality and technical
investigations.Your background should include;
- 5 - 8+ years of related experience with a BS/BA or higher
degree in Engineering, Physics, Chemistry or Life Sciences or
equivalent work experience.
- Demonstrated ability to successfully lead, coach, and mentor
junior level engineers.
- Excellent communication skills to work as a leader and provide
internal customer support.
- Excellent time management skills to support a fast paced
- Excellent troubleshooting and root cause analysis skills in
both hardware and software.
- Strong experience with writing and implementing test protocols
- Strong industrial electrical and mechanical knowledge.
- Knowledge of IT networking and systems infrastructure.
- Experience working in a clinical laboratory regulated
- Experience executing within a computerized
maintenance/calibration management system.
- Knowledge Safety Training, lock out tag out (LOTO), Hazardous
material, and waste handling.
- Strong experience in technical troubleshooting and maintenance
in both hardware and software components in regards to liquid
handling equipment.(e.g., Agilent, Hamilton, Labcyte, Illumina
etc.)Hands-on experience supporting equipment in a high throughput
clinical laboratory operation.
- Experience with Laboratory Information Management Systems
(LIMS), Manufacturing Management Systems(MES), scheduling software,
Customer Relationship Management (CRM) software.
- Knowledge of molecular biology to best support equipment
activities in an next generation sequencing (NGS) workflow.
- Project management skills.
- Experience working with Green Button Go (GBG).Experience
working with Illumina NGS technology platforms.
- Physical Demands/Working Environment:
- 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.
- Travel up to 10% of the timeListed 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.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 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 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.
Keywords: GRAIL, Raleigh , Senior Operations Engineer - RTP - 2822, Engineering , Raleigh, North Carolina
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