Validation Engineer

Job Title: Validation Engineer (GMP / CQV)Location: Bothell, Washington, United StatesIndustry: Pharmaceuticals / BiotechnologyFunction: Quality Assurance / Validation / EngineeringEmployment Type: Full-timeAbout the RoleWe are seeking a Validation Engineer to support GMP manufacturing and laboratory operations in a highly regulated environment. This role is focused on commissioning, qualification, and validation (CQV) activities across equipment, systems, and facilities, ensuring compliance with global regulatory standards and maintaining a validated state across the site.You will act as a key validation subject matter expert (SME), working closely with cross-functional teams to support manufacturing operations, quality systems, and regulatory readiness.What You’ll DoDevelop and execute validation protocols, risk assessments, and qualification strategiesPerform equipment, utility, and facility qualifications (IQ/OQ/PQ)Support change controls, capital projects, and ongoing validation activitiesAct as validation SME across Manufacturing, QA, QC, Engineering, IT, and Supply Chain teamsSupport regulatory inspections and internal/external auditsLead or contribute to deviation investigations, CAPA, and root cause analysisEnsure compliance with GMP, GDP, GxP, FDA, EU GMP Annex 15, 21 CFR Part 11, and data integrity requirementsMaintain and review validation documentation (URS, protocols, reports, lifecycle documents)Identify and support continuous improvement initiatives to improve efficiency and reduce validation cycle timesProvide training and guidance on validation principles and best practicesManage multiple priorities across validation projects and stakeholdersWhat We’re Looking ForBachelor’s degree in Life Sciences, Engineering, or related STEM discipline2+ years of experience in CQV / validation within pharmaceutical or biotech environmentsStrong understanding of GMP regulations and validation lifecycle (IQ/OQ/PQ, URS, CSV)Experience with equipment, utility, and facility qualificationKnowledge of FDA, EU GMP Annex 15, ICH guidelines, and GAMP5 principlesExperience with deviations, investigations, and CAPA processes (preferred)Strong technical writing, documentation, and communication skillsAbility to work cross-functionally in a regulated, fast-paced environmentNice to HaveExperience in biotech, pharma, or cell therapy manufacturingExposure to computer system validation (CSV)Familiarity with electronic quality/document management systemsExperience supporting regulatory inspections or auditsCompensation & BenefitsBase salary: $83,220 – $100,847 USDBonus and equity eligibility (based on role and performance)Competitive benefits package including healthcare, retirement, and wellbeing programsPaid time off and flexible leave optionsWork EnvironmentOnsite role within a GMP manufacturing / laboratory environmentCollaboration-heavy, cross-functional settingSome flexibility may apply depending on site designation, but this is primarily an onsite validation role due to operational requirementsWhy ApplyThis is a high-impact role for someone who enjoys hands-on validation work, regulatory interaction, and cross-functional collaboration. You’ll be part of a team that directly supports the delivery of life-changing therapies through robust, compliant manufacturing systems.