Project Leader

Project Leader, Clinical Research, Full-time w/ benefits, Portland, Oregon (OR)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

• Previous experience supporting laboratory operations, equipment qualification/validation, quality systems, or regulated environments.

• Experience with equipment lifecycle activities, including installation, qualification, maintenance, and documentation preferred.

• Knowledge of cGMP, GLP, CFR requirements, ISO standards, and regulated laboratory environments preferred.

• Experience working with environmental monitoring systems (including REES is strongly preferred.)

• Strong technical writing, document control, and editing skills.

• Ability to manage multiple priorities and adapt quickly when operational issues arise.

• Strong collaboration and communication skills with the ability to work effectively across departments.

• Demonstrated attention to detail and commitment to quality and compliance.

#LI-HD1

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply