Automation CSV Engineer

Automation CSV Engineer

Role Type: Contract to Hire , Full-Time | Hybrid 3x per week

Location: Seattle, WA

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About our Client

At our core, we believe curiosity drives innovation. As a forward-thinking team, we thrive on challenging the status quo, learning continuously, and pushing boundaries. We are on a mission to create an inclusive environment where curiosity is celebrated and big ideas shape the future. If you are someone who asks questions, seeks answers, and isn't afraid to dive deep, join us!

Role Overview

The Automation CSV Engineer provides validation, compliance, testing, and lifecycle documentation support for GMP automation and computerized systems in a regulated manufacturing environment. Working cross-functionally across Automation, QA, IT, Engineering, and Operations, you will apply risk-based validation practices to ensure control systems remain fit for purpose, reliable, and compliant with regulatory standards.

Key Responsibilities

• System Validation Strategy: Develop risk-based lifecycle validation strategies for automation platforms (e.g., Emerson DeltaV, SCADA, PLCs, AVEVA/OSIsoft PI, batch systems). Lead validation activities for new system implementations, upgrades, modifications, and decommissioning.
• Lifecycle Documentation: Author, review, and execute core validation deliverables, including Validation Plans, URS, FRS, Risk Assessments, RTMs, FAT/SAT, IQ/OQ/PQ protocols, test scripts, deviations, summary reports, and SOPs.
• Testing & Execution: Coordinate and execute functional, regression, and qualification testing. Verify control logic (sequences, recipes, interlocks, alarms) and objective evidence against design specifications. Troubleshoot and document discrepancies to resolution.
• Data Integrity & Compliance: Facilitate risk and data integrity assessments in accordance with ALCOA+ principles, 21 CFR Part 11, EU Annex 11, and GAMP 5. Maintain systems in a validated state through periodic reviews, access control reviews, and audit trail evaluations.
• Change Control & Quality Systems: Provide technical impact assessments for proposed hardware/software/configuration changes within formal quality systems (Change Control, Deviations, CAPAs). Support internal/external audits and regulatory inspection readiness.
• Cross-Functional Collaboration: Partner with internal teams and external vendors/system integrators to align technical execution with site compliance standards and project timelines.

Qualifications

Required:

• Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical field (or equivalent combination of education and experience).
• Experience: 5+ years of experience in automation system validation (CSV), commissioning and qualification, or automation quality within a regulated (GMP) environment.
• Technical Proficiency: Hands-on experience with industrial automation technologies such as Emerson DeltaV, AVEVA/OSIsoft PI, SCADA, PLCs, or batch systems.
• Compliance Knowledge: In-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity principles, and risk-based Computerized System Assurance (CSA).
• Core Skills: Strong technical writing, systematic documentation, problem-solving, and cross-functional communication abilities.

Preferred:

• Direct experience validating Emerson DeltaV systems in pharmaceutical, biotech, or gene therapy manufacturing.
• Familiarity with MES, process historians, laboratory systems, eQMS, or building automation platforms (BAS).
• Experience leveraging vendor testing/documentation and supporting regulatory agency audits.

Work Environment & Travel

• Flexibility: Occasional schedule flexibility required during system cutovers, testing campaigns, and manufacturing shutdowns.
• Safety: Ability to work in controlled manufacturing and laboratory environments in accordance with gowning and safety rules.

Why Join Us?

• Growth & Mentorship: Access continuous learning, professional development, and career growth opportunities.
• Innovative Impact: Work with state-of-the-art technologies on high-impact projects.
• Inclusive Culture: Work in a collaborative environment where diverse perspectives and new ideas are valued.

Ready to Apply?

If you have a curious mind and a passion for engineering compliance excellence, we want to hear from you. Apply today and see where your journey takes you!