Senior Validation Engineer

Senior Validation Engineer - US, Seattle - 4 Months Initial Contract

Our client, a global biotechnology organisation, is recruiting for a Senior Validation Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a Senior Validation Engineer to help expand our client's biotech operations throughout Europe. As the Senior Validation Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.

What you’ll do:

• Lead the planning, development, and execution of EMPQ protocols (IQ/OQ/PQ) for new and existing equipment, utilities, and process systems.
• Write clear, compliant, and technically robust EMPQ protocols aligned with GMP, GAMP 5, and site validation master plans.
• Execute EMPQ protocols on the manufacturing floor, ensuring accurate data capture and adherence to safety and GMP requirements.
• Ensure validation activities comply with FDA, MHRA, EU Annex 15, and other applicable regulatory frameworks.
• Partner with Engineering, Facilities, Manufacturing, Quality Assurance, and external vendors to ensure equipment readiness and qualification success.

What you’ll need:

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• Extensive experience in validation within GMP-regulated industries (pharmaceutical, biotech, medical devices, or similar).
• Proven expertise in EMPQ, including authoring and executing IQ/OQ/PQ protocols.
• Strong understanding of regulatory requirements: FDA 21 CFR Parts 210/211, EU GMP, Annex 15, GAMP 5.
• Exceptional technical writing skills and ability to produce clear, audit-ready documentation.

If this role is of interest, please apply now!
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