Automation CSV Engineer - Site Based, Redmond, WA

What You’ll Do

Automation Validation & Compliance Support

• Support validation and lifecycle management activities for GMP automation systems including DeltaV, PI, SCADA, PLC, and associated manufacturing control platforms.
• Assist in ensuring automation systems remain compliant with GxP regulations, internal procedures, and industry standards throughout the system lifecycle.
• Participate in implementation, upgrade, patching, migration, and change control activities for automation systems.
• Support maintenance of the validated state for manufacturing automation systems and associated infrastructure.

Validation Documentation & Technical Writing

• Author, revise, review, and maintain validation lifecycle documentation including Validation Plans, IQ/OQ/PQ Protocols, Test Scripts, Traceability Matrices, Functional Specifications, Discrepancy Reports, Summary Reports, SOPs and Work Instructions.
• Ensure validation documentation is accurate, complete, and aligned with internal quality standards and regulatory expectations.
• Support document review and approval workflows within electronic quality management systems.

Testing & Execution Support

• Execute and support commissioning, qualification, and validation testing activities including FAT, SAT, IQ, OQ, PQ, and automation functional testing.
• Document test execution results, discrepancies, deviations, and corrective actions in accordance with approved procedures.
• Coordinate testing activities with Automation, QA, ITCSV, Validation, and system owners to support project timelines and operational readiness.
• Assist with troubleshooting issues identified during testing and support resolution activities.

Cross-Functional Collaboration

• Serve as a liaison between QA, Automation, ITCSV, Engineering, and Manufacturing teams to support alignment of validation and compliance activities.
• Collaborate with system owners and technical SMEs to gather system requirements and support risk assessments for automation systems.
• Participate in project meetings, change control reviews, deviation investigations, and quality discussions related to automation systems.
• Support vendor and integrator coordination activities as needed for system implementations and upgrades.

Risk-Based Validation & Quality Systems

• Support risk-based validation approaches aligned with FDA CSA principles, GAMP 5 guidance, and Data Integrity expectations.
• Assist in execution of Quality Risk Management (QRM) activities related to automation systems and computerized systems.
• Support periodic reviews, audit readiness activities, and inspection support for validated automation systems.
• Participate in continuous improvement initiatives focused on validation efficiency, documentation quality, and testing practices.

Automation System Support

• Assist in reviewing automation system configurations, interfaces, alarms, security settings, and process control functionality for compliance and validation impact.
• Support data integrity assessments, user access reviews, backup verification, and audit trail review activities where applicable.
• Work with Automation and IT teams to support system reliability, compliance, and operational continuity.
• Maintain awareness of current regulatory guidance and industry best practices related to CSV and automation validation.

Position Requirements

• Bachelor’s degree in Engineering, Computer Science, Biotechnology, Information Systems, or related technical discipline preferred.
• Minimum of 5 years of experience supporting GMP automation systems, computer system validation (CSV), automation testing, or technical writing activities within regulated industries.
• Hands-on experience with automation platforms such as DeltaV, PI, SCADA, PLC, or related manufacturing systems.
• Experience executing validation and qualification activities including FAT, SAT, IQ, OQ, PQ, and functional testing.
• Strong technical writing skills with experience authoring validation documentation and compliance records.
• Working knowledge of GxP regulations and industry guidance including 21 CFR Part 11, Annex 11, GAMP 5, FDA CSA principles, Data Integrity requirements.
• Understanding of automation system lifecycle management and pharmaceutical quality systems.
• Experience supporting change controls, deviations, CAPAs, and risk assessments within GMP environments.
• Strong organizational skills and attention to detail with the ability to manage multiple assignments simultaneously.
• Effective communication and collaboration skills with the ability to work across technical and business functions.

Preferred Qualifications

• Experience supporting pharmaceutical, biotechnology, cell therapy, gene therapy, or medical device manufacturing operations.
• Familiarity with MES, historians, batch systems, or manufacturing data systems.
• Exposure to electronic quality management systems (eQMS), document management systems, and change management processes.
• Experience supporting regulatory inspections or internal audits.
• Understanding of SDLC methodologies and risk-based validation practices.
• Knowledge of networking, system interfaces, or industrial automation infrastructure concepts.
• Experience working with system integrators, vendors, or third-party validation providers.

Travel & Work Flexibility

• Occasional travel to manufacturing or project sites may be required.
• Flexibility in working hours may be needed during validation execution, project support activities, or manufacturing shutdown windows.