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18 Jan 2022

Temporary Validation Engineer (22-01600)

iris.chen@axelon.com Bothell, Washington, United States

Job Description

This will be a hybrid role composed of both onsite and remote work. M-F

Job Description:
The primary functions of this role will be to support Validation activities as they pertain to Jump in Bothell, WA. Qualification may include on-site equipment testing activities.

The duties and responsibilities of the role are as follows:
• Support equipment qualification projects
o Work cross-functionally with Validation, Quality, and System Owner groups to manage IQ/OQ/PQ execution in accordance with project timelines.
o Complete all validation package documents (e.g., IQ/OQ/PQ, Summary Report, Traceability Matrices) including management of stakeholder review and approval.
o Develop lifecycle documents for new assets. This includes Configuration Specifications (CS) and User Requirement Specifications (URS).
• Support the Periodic Review and Requalification program as needed
o Complete Periodic Reviews and Requalification activities as needed
o Temperature mapping of temperature-controlled chambers using the Kaye Validator
• Support other Validation projects/deliverables as needed
o This includes but is not limited to: Technical assessments for equipment maintenance events or changes, cleanroom classification studies, EMPQ, etc.

Experience Required:
• Bachelor’s Degree in Engineering or Life Science
• 2+ years of experience in a cGMP Pharmaceutical/Biologics/Cell Therapy Manufacturing facility, preferably in Validation or other Engineering capacity.

Preferred Experience:
• Experience writing and executing IQ/OQ/PQ protocols and Summary Reports
• Experience with Cell Therapy equipment (e.g. Xuri Wave Bioreactors, temperature controlled chambers, etc)
• Experience with ValGenesis, Blue Mountain/Maximo/SAP, Trackwise or other Quality Record Management system.
• Temperature mapping experience, particularly with the Kaye Validator.

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How to Apply

Please share Resumes to Iris.chen@axelon.com to apply.

Job Types: Temporary.

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