ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Project Leader
The Project Leader will partner closely with the Senior Project Leader to support laboratory operations, equipment lifecycle management, compliance initiatives, and continuous improvement activities within our Portland, Oregon laboratory. This role serves as a key cross-functional resource, helping ensure laboratory equipment, documentation, and quality systems remain inspection and audit ready.
The Role
Key Responsibilities
•
Support qualification, validation, and maintenance activities for laboratory equipment, including IQ/OQ/PQ documentation and execution.
•
Assist with equipment lifecycle management, preventative maintenance coordination, calibration tracking, and troubleshooting activities.
•
Draft, edit, review, and maintain controlled laboratory documents, procedures, forms, and records.
•
Support audit and inspection readiness activities, including preparation for customer, regulatory, and internal audits.
•
Assist with compliance initiatives related to CFR requirements, ISO standards, and applicable quality systems.
•
Partner with laboratory teams to investigate equipment-related issues and support resolution of unexpected results or operational challenges.
•
Coordinate and support WebEx and virtual equipment qualification activities as required.
•
Work cross-functionally with laboratory operations, quality, validation, engineering, and project teams to ensure business priorities are achieved.
•
Provide support across multiple initiatives and projects, contributing to operational excellence and continuous improvement efforts.
•
Maintain accurate records and documentation to support compliance, traceability, and project tracking.
You Will Need
•
Associate’s degree in a scientific, technical, engineering, or related discipline required; bachelor’s degree preferred.