Operations Engineer 2, MSAT # 4411 at GRAIL

Durham, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, BiotechnologyIndustries

Requirements

BS/BA or equivalent in Engineering, Physics, Chemistry or Life Sciences with 2+ years of experience
Strong interpersonal, organizational, and troubleshooting skills

Responsibilities

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 in a timely manner
Make time sensitive technical decisions; collaborate and escalate when appropriate
Ensure day-to-day reliability and maintainability of equipment, processes, mechanical, electrical, control, and safety/security systems following cGMP/GLP and Quality Management System (eQMS) guidelines
Reduce and improve unplanned maintenance events wherever feasible, ensuring efficient and productive operation of equipment
Execute and document equipment lifecycle related activities (installations, maintenance, calibration, 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 requirements
Maintain Asset Management System(s) to support internal Equipment Program processes and procedures
Execute procedures, work instructions, guidelines, and testing documents such as installation /operational / performance qualification (IOPQ), site acceptance test (SAT), verifications, standard operating procedures (SOP)
Serve as a primary point of contact for hosting vendor IQ, OQ, calibration, PM, and/or repairs with minimal supervision
Ensure that all work performed by external contractors is completed and documented in accordance with the site Quality Management System (QMS) and safety guidelines
Work closely with quality and regulatory to determine, include, implement and follow the required policies, requirements, and procedures for equipment lifecycle events
Author and lead DAR implementations where needed; may lead equipment and equipment integration-related Change Controls for qualified assets
Respond to environmental monitoring system alert notifications for areas of responsibility

Skills

Key technologies and capabilities for this role

troubleshootingequipment maintenancenext-generation sequencingNGSautomated liquid handlingregulatory compliancedebuggingrepairslaboratory equipment

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is a full-time, onsite position working in the Research Triangle Park, NC lab.

What are the working hours for this role?

This is a first shift position, Monday to Friday starting at 8:00AM, with possible work on holidays, on-call requirements, and temporary adjustments due to training, travel, or other events.

What skills are essential for this Operations Engineer role?

Strong interpersonal, organizational, and troubleshooting skills are essential, along with the ability to lead troubleshooting, recovery, debugging, repairs, and maintenance of laboratory equipment following cGMP/GLP and QMS guidelines.

What is the salary or compensation for this position?

This information is not specified in the job description.

What kind of experience makes a strong candidate for this role?

Candidates with experience in installing, maintaining, and troubleshooting cutting-edge laboratory equipment like next-generation sequencing platforms and automated liquid handling robots, while ensuring regulatory compliance with cGMP/GLP, CLIA/CAP, FDA 21 CFR part 820, and ISO 13485, will stand out.

GRAIL

Develops blood tests for early cancer detection

About GRAIL

GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.

Menlo Park, CaliforniaHeadquarters

2016Year Founded

$1,765.5MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Risks

Potential overdiagnosis could impact the perceived value of GRAIL's tests.

Significant net losses may affect investor confidence and long-term sustainability.

High test costs may limit accessibility in markets with less healthcare funding.

Differentiation

GRAIL uses high-intensity sequencing for early cancer detection via blood tests.

The Galleri test screens for over 50 cancers with a single blood draw.

GRAIL's tests are supported by large-scale clinical studies ensuring reliability.

Upsides

Collaborations with platforms like Function Health expand Galleri test accessibility.

Revenue from Galleri grew 52% year-over-year, indicating strong market demand.

GRAIL's technology aligns with trends in personalized and preventative medicine.

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