Process Engineer 2 - Engineering Assurance # 4293

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.
This role manages the full lifecycle of lab and manufacturing assets, ensuring all activities—installations, qualifications, calibrations, and decommissions—are executed in compliance with cGMP/GLP, QMS, and regulatory standards (e.g., CLIA/CAP, FDA 21 CFR Part 820, ISO 13485). It involves creating and maintaining documentation (e.g., SOPs, IOPQs, SATs), coordinating cross-functional teams, and driving projects to support compliant operations, system upgrades, and workflow improvements.

Responsibilities:

• Plan and execute qualifications and related processes to onboard, replace, modify, upgrade, and decommission assets, ensuring alignment with cGMP/GLP and Quality Management System (QMS) guidelines.
• Coordinate and document all equipment lifecycle activities—including installations, calibrations, maintenance, qualifications, and decommissions—by maintaining accurate equipment records in asset management and quality management systems, ensuring traceability and compliance with CLIA/CAP, FDA 21 CFR Part 820, ISO 15189, ISO 13485, and other relevant standards.
• Create, update, and review procedures, work instructions, guidelines, and testing documents such as installation/operational/performance qualification (IOPQ), site acceptance testing (SAT), verifications, and standard operating procedures (SOPs).
• Collaborate closely with Quality and Regulatory teams to implement and adhere to required policies and procedures for asset qualification, calibration, maintenance, and software validation.
• Based on the project, define tasks, assign owners, and establish timelines to ensure clear accountability and on-time delivery.
• Proactively coordinate resources to support qualifications, installations, calibrations, investigations, upgrades, and repairs as needed, ensuring projects are delivered on time and meet critical business objectives.
• Partner with software teams to enable effective technology transfer and continuous workflow improvements.
• Support the needs of the engineering operations group, providing technical and organizational expertise.

Preferred Qualifications:

• Bachelor’s degree in engineering, life sciences, or a related technical field.
• 3+ years of experience in equipment qualification, asset lifecycle management, or engineering operations within a regulated environment (e.g., diagnostics, medical devices, pharma, or biotech).
• Strong knowledge of cGMP, GLP, and Quality Management Systems.
• Experience working under regulatory frameworks such as CLIA, CAP, FDA 21 CFR Part 820, ISO 13485, and/or ISO 15189.
• Hands-on experience authoring and executing qualification protocols (IOPQ, SAT, FAT), verifications, and SOPs.
• Proficiency with equipment asset management and quality systems (e.g., CMMS, QMS software).
• Demonstrated ability to manage cross-functional projects, timelines, and resource coordination.
• Excellent written and verbal communication skills, with strong attention to detail.

Physical Demands and 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.

Expected full time annual base range for this position is $82,000 - $96,000. 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 co