Senior Process Engineer - Systems #4072

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 Sr Process Engineer - Systems for the Engineering Operations Department.

The Sr Process Engineer - Systems will provide expertise, improve processes, and sustain a variety of engineering systems and engineering processes to support dynamic and compliant lab operations. The process engineer will primarily interact with operations, development, quality, and procurement to ensure smooth running of a complex operation system. This includes sustaining local operations and collaborating globally to continuously improve our processes by helping gather requirements and prioritize improvements. Candidates would ideally have hands-on experience in applying analytical thinking skills to assess, recommend, and implement technical solutions in systems like enterprise asset management, independently driving process improvements, and documenting within a regulated environment. This individual will work in a resilient team-oriented environment that supports multiple operations and technologies to help deliver our revolutionary test to as many people as possible.

The on-site role requires 5 days a week in Durham, NC (RTP Site)

This is a full time position working in our lab with a start time of 8:00 AM Monday through Friday (first shift)

The working hours could be temporarily adjusted due to training, travel, and other events.

This position may need to support weekends and holidays.

Responsibilities

• Lead multiple systems to support internal Equipment Program processes and procedures.
• Apply analytical thinking skills to diagnose, make recommendations, and implement systems.
• Incorporate knowledge of business and technology and develop and lead implementation of plans for approved solutions.
• Translate data gathered from user discussions into business requirements.
• Identify business/system needs and lead solutions.
• Lead, implement, and execute testing strategies and develop preliminary findings.
• Support multiple systems performance and reliability.
• Prepare reports, metrics, and other tracking tools measuring / allowing for success.
• Actively represent areas in audits.
• Execute timely processing of investigations, impact assessment, Change Controls, NCRs, deviations, and CAPAs.
• Execute analysis of data from multiple sources and help the team balance efficiency, cost of goods, and system uptime while maintaining a safe and compliant work environment.
• Update, maintain, and execute, test plans, user manuals, process flow charts, software qualification, engineering reports, verifications, work instructions, and standard operating procedures (SOPs) as needed.
• Provide technical training, create new training, and transfer knowledge to fellow engineers and operators.
• Participate and adhere to GRAIL’s policies and guidelines.
• Recommend and implement changes to ensure ongoing high-quality performance of engineering systems as part of the continuous improvement process.
• Lead and execute identification of and solutions to the root cause of process discrepancies, deviations and non-conformances.

Preferred Qualifications:

• 5+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience
• 3+ years working with equipment and systems.
• 3+ years in data management
• 2+ years experience in data entry / analytics development
• 2+ years in design experience of systems infrastructure
• 1+ years usage of Asset Management Lifecycle
• 1+ year working knowledge of IT networking and systems infrastructure.
• 1+ year experience in Project Management preferably utilizing Agile methodologies (e.g., Scrum, Kanban) to iteratively plan, execute, and optimize tasks
• Excellent problem solving, analytical, root cause analysis, and troubleshooting skills
• Excellent communication skills to work independently and provide internal customer support
• Excellent time management skills to support a fast paced working environment
• Excellent knowledge writing and executing SOP’s, Work Instructions, or Test Protocols
• Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting
• Experience working under cGxP (Documentation, Manufacturing, Automation Manufacturing, Laboratory) ISO 13485 or FDA regulated environment
• Excellent technical troubleshooting skills and logic proficiency
• Excellent problem solving and analytical skills
• Experience with Environmental Monitoring Systems
• Experience with Enterprise Asset Management Systems (HxGN EAM preferred)
• Knowledge of PL/SQL, Python, JSON, RESTful API integration, and/or Middleware is highly desirable
• Ability to travel up to 10% of the time

Physical Demands & Working Environment

• Hours and days may vary depending on operational needs
• 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.
• Working with dry ice may be necessary.
• Working on confined spaces may be necessary
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.

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 to request accommodation. GRAIL maintains a drug-free workplace.