Equipment Operations Engineer II

About the role

The Equipment Operations Engineer II at Veracyte is responsible for ensuring the reliability, compliance, and operational availability of laboratory equipment across clinical and research environments. The role involves optimizing and adhering to the equipment lifecycle program and processes, managing equipment systems, coordinating maintenance and calibration activities, maintaining accurate documentation, and supporting investigations and development of equipment maintenance strategies.

Responsibilities

• Support optimization and adherence to the equipment lifecycle program and processes from procurement, installation, qualification (IQ/OQ/PQ), calibration, and preventive maintenance to decommissioning.
• Support management of equipment systems, including internal investigations and service coordination, documentation, and continuous improvement related to equipment performance. Troubleshoot and support root cause investigations for equipment failures and implement correct actions. Adhere to existing maintenance and Ops SOP’s when performing internal maintenance.
• Support cross-functional efforts related to new equipment onboarding, equipment relocations, obsolescence planning, and lab expansions.
• Carefully coordinate maintenance, calibration, verification, and qualification activities across internal stakeholders (R&D and CLIA) and external service vendors to minimize impact on lab workflows while ensuring regulatory compliance.
• Maintain accurate and compliant documentation for all equipment-related activities, support audits, inspections, and internal reviews.
• Support development of equipment maintenance strategies to minimize downtime and increase overall equipment reliability.
• Support investigations as Subject Matter Expert (SME) in Non-Conformance Reports (NCRs) and Corrective Action Plan (CAPA)s as needed.
• Support development and authoring of equipment specifications, user requirements, and IQ/OQ protocols. Support equipment qualification activities.
• Ensure all equipment and processes meet quality and regulatory standards (CLIA, CAP, IVD, and/or FDA regulations).
• Adhere to procedures and policies outlined within Veracyte’s quality management system.

Qualifications

• 2-4 years of related experience with a BS/BA or higher degree in an Engineering field or equivalent work experience.
• 2-4 years of hands-on experience in equipment engineering or reliability engineering within a highly regulated environment.
• 1-2 years of experience developing/writing equipment qualification plans, calibration strategies, and maintenance & operation procedures.
• Familiarity with lab instrumentation, preventive maintenance, and calibration standards.
• Effective analytical and problem-solving skills with the ability to diagnose complex equipment issues and drive resolution independently or collaboratively.
• Proficient with common software tools (e.g. Microsoft Office, Google Suite).
• Strong organizational skills with a keen attention to detail and documentation accuracy.
• Effective communication and interpersonal skills; ability to work cross-functionally.
• Excellent time management skills to support a fast-paced working environment.

Preferred Qualifications

• Experience with sequencing assays and automation platforms.
• Familiarity with CMMS (BMRAM, Limble, EAM, SAP) and LIMS integration.
• Working knowledge of root cause analysis tools (e.g. 5 whys, fishbone, FMEA) and reliability principles.
• Experience with Six Sigma principals, SSGB or other reliability certification a significant plus.