Validation Associate Engineer
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Validation Associate Engineer Key Responsibilities Support the Periodic Review and Periodic Requalification program (Bothell, WA and Seattle, WA), including temperature mapping studies and development of Periodic Reviews.
With oversight, generate validation protocols, specifications, reports, and qualification plans for GMP operations.
Perform Validation Impact Assessments for work orders of qualified equipment, utilities, and facilities.
Support qualification work from change controls, capital projects, and supplemental validation deliverables per approved plans (under a senior Validation Engineer).
Collaborate with cross‑functional teams (Facilities/Engineering, IT, Manufacturing, QC, Supply Chain, QA, and Validation).
Qualifications & Experience Bachelor’s degree in life sciences/engineering/STEM (or equivalent).
2 years’ GMP experience (pharmaceutical manufacturing operations/support preferred).
Recommended: commissioning/qualification/validation (CQV) in regulated industries.
Awareness of cGMP/GDP/GXP/GAMP5, including 21 CFR Part 11, computer systems validation, EU GMP Annex 15, and data integrity.
Beneficial: equipment/utility/facility qualification CQV practices; investigations/deviations/CAPA.
Beneficial: validation lifecycle deliverables (URS through IQ/OQ/PQ/SR) and computer system validation (CSV) through retirement.
Required: strong project/program management, communication, and technical writing.
Desired: electronic document management systems.
Benefits / Compensation (explicit) Health coverage (medical/pharmacy/dental/vision), wellbeing support, and financial protection (401(k), disability, life insurance, etc.).
Bothell, WA: $83,220–$100,847.
Application Instruction If the role doesn’t perfectly match your resume, apply anyway.
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