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Validation Engineer
Job in
Seattle, King County, Washington, 98127, USA
Listed on 2026-02-16
Listing for:
QCS Staffing
Full Time
position Listed on 2026-02-16
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Overview
Our client, a global biotechnology organisation, is recruiting for a 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 Validation Engineer to help expand our client's biotech operations throughout Europe. As the Validation Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900 m2.
WhatYou’ll Do
- Plan, develop, and execute qualification activities (URS, RA, IQ/OQ/PQ) for QC laboratory instruments and systems.
- Author clear, compliant qualification protocols and reports for QC equipment.
- Maintain qualification status throughout the equipment lifecycle, including periodic reviews, requalification, and retirement.
- Ensure QC equipment qualification meets regulatory requirements (FDA, MHRA, EU GMP, Annex 15).
- Work closely with QC analysts, QA, Engineering, IT, and vendors to ensure equipment readiness and compliance.
- Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field.
- Experience in a GMP-regulated QC laboratory environment (pharmaceutical, biotech, ATMP, or medical devices).
- Hands-on experience with QC equipment qualification (IQ/OQ/PQ).
- Strong understanding of analytical laboratory instruments (e.g., HPLC, GC, UV-Vis, PCR, balances, incubators).
- Excellent technical writing and documentation skills.
If this role is of interest, please apply now!
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