Automation CSV Engineer - Site Based, Redmond, WA

Job Title:

Automation CSV Engineer

Location:

Redmond, WA
Department:
Global MSAT

The Automation CSV Engineer is responsible for supporting validation, compliance, testing, and technical documentation activities for GMP automation systems within a regulated manufacturing environment. This role partners closely with Automation, Quality Assurance (QA), IT CSV, Manufacturing, and Engineering teams to help ensure automation systems remain compliant, reliable, and maintained in a validated state throughout the system lifecycle.

Key responsibilities include supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related automation platforms.

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.

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.

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.

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.

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.

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.

• Bachelor’s degree in Engineering, Computer Science, Biotechnology, Information Systems, or a related technical discipline preferred.

• Minimum of 5 years of…