Automation CSV Engineer - Site Based, Redmond, WA

The Automation CSV Engineer supports validation, compliance, testing, and technical documentation for GMP automation systems in a regulated manufacturing environment.

What You’ll Do:
- Support validation and lifecycle management for GMP automation systems (DeltaV, PI, SCADA, PLC and related platforms)
- Maintain compliance with GxP regulations, internal procedures, and industry standards
- Participate in implementation, upgrades, patching, migration, and change control
- Maintain the validated state of automation systems and infrastructure
- Author/revise/review/maintain validation documentation (plans, IQ/OQ/PQ protocols, test scripts, traceability matrices, functional specs, discrepancy/summary reports, SOPs, work instructions)
- Execute/support FAT, SAT, IQ, OQ, PQ, and functional testing; document results, deviations, and corrective actions
- Liaise with QA, Automation, IT CSV, Engineering, and Manufacturing; support requirements gathering and risk assessments; participate in change control/deviation investigations
- Support risk-based validation (FDA CSA, GAMP 5, data integrity) and QRM; periodic reviews/audit readiness
- Review automation configurations, interfaces, alarms, security settings, and interfaces; support data integrity assessments (access, backups, audit trails)

Position Requirements:
- Minimum 5 years supporting GMP automation systems/CSV, automation testing, or technical writing in regulated industries
- Hands-on experience with DeltaV, PI, SCADA, or PLC systems
- Experience executing FAT/SAT/IQ/OQ/PQ and functional testing
- Strong technical writing for validation/compliance records
- Knowledge of GxP (21 CFR Part 11, Annex 11, GAMP 5, FDA CSA, data integrity)
- Experience with lifecycle management, change controls/deviations/CAPAs, and risk assessments
- Strong organizational, detail, and cross-functional collaboration skills

Preferred Qualifications:
- Pharma/biotech/cell therapy/gene therapy/med device manufacturing experience
- Familiarity with MES, historians, batch systems, or manufacturing data systems
- eQMS/document management/change management exposure; inspection/audit support
- SDLC and networking/industrial automation infrastructure knowledge
- Experience with system integrators/vendors/third-party validation

Travel & Work Flexibility:
- Occasional travel; flexible hours during validation/project/manufacturing shutdowns

Compensation & Benefits (as stated):
- Base pay range: $115,000–$126,500; plus discretionary annual bonus; Medical/Dental/Vision; disability; basic life insurance; 401k match; flexible work; paid time off/holidays; wellness/transportation benefits.

Application Instructions:
- Apply today.