Sr. Cleaning Validation Engineer/Manager (Bothell)

About Company: Who Are We? ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets. Why explore your future at ELIQUENT?

ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity.

At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way. About the Role: 10+ years in pharma/biotech/medical device validation - some biologics experience is required. Strong multi-discipline validation expertise , including: Cleaning Validation Utilities (PW, WFI, HVAC, compressed air) Equipment Qualification (IQ/OQ/PQ) Computer Systems Validation (CSV, GAMP 5, Part 11) Shipping/Distribution Validation Proven leadership / people management experience Deep knowledge of: FDA 21 CFR Part 11, 210/211 EU GMP Annex 11 ICH Q7 / Q10 Strong technical writing and document review skills Experience supporting FDA inspections / audit readiness Bachelor’s required; advanced degree preferred