Senior Validation Engineer - US, Seattle - 4 Months Initial ContractOur 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!#LI-CO1