Automation CSV Engineer - Site Based, Redmond, WA

Role: Support validation, compliance, testing, and technical documentation for GMP automation systems within a regulated biopharma manufacturing environment. Responsibilities include lifecycle management of automation platforms (DeltaV, PI, SCADA, PLC), authoring validation documentation, executing validation testing (IQ, OQ, PQ), and ensuring automation systems meet GxP standards and industry guidelines (21 CFR Part 11, GAMP 5). Collaborate across Automation, QA, IT CSV, Manufacturing, and Engineering teams to maintain system integrity, support change controls, risk assessments, and audits, and support continuous improvement initiatives. Requirements: Bachelor’s in Engineering, Computer Science, or related field; 5+ years supporting GMP automation and CSV activities; hands-on experience with DeltaV, PI, SCADA, PLC; strong technical writing skills; knowledge of GxP, regulatory requirements, and automation lifecycle management; experience supporting validation, change control, deviations, and risk assessments. Preferred: experience with biopharma manufacturing (cell/gene therapy, biotech, pharma), electronic quality systems, regulatory audits, and automation infrastructure. The role is based in Redmond, WA, with occasional travel; work schedule flexibility may be required. The position offers growth opportunities, a flexible work environment, and exposure to innovative biopharma manufacturing projects, emphasizing validation excellence and cross-functional collaboration.