Automation CSV Engineer - Site , Redmond, WA

Job Title: Automation CSV Engineer

Location: Redmond, WA

Department: Global MSAT

About Us:

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Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #Be Curious with us and see where your curiosity can take you!

The Role: 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.

Experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related automation platforms is required. This position requires strong technical writing skills, attention to detail, and the ability to collaborate effectively across cross-functional teams in support of GMP manufacturing operations.

• 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, IT CSV, 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, IT CSV, 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…