Automation CSV Engineer - Site Based, Redmond, WA

Job Title: Automation CSV Engineer

Location: Redmond, WA

Department: Global MSAT

About Us: this is who we are

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

The Role: / your challenge, …in our journey

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.

What You’ll Do:

Position Summary

The Automation CSV Engineer provides validation and compliance support for automation and computerized systems used in GMP manufacturing operations. The position is responsible for developing validation strategies, preparing and executing lifecycle documentation, assessing automation changes, and helping maintain systems in a controlled and validated state.

This role works across Automation, Quality Assurance, IT, Manufacturing, Engineering, Validation, and external service providers. The engineer will apply technical knowledge of manufacturing control systems and risk-based validation practices to support system implementations, upgrades, modifications, periodic reviews, and ongoing operations.

Successful candidates will have practical experience with platforms such as Emerson DeltaV, OSIsoft PI or AVEVA PI System, SCADA, PLC-based controls, batch systems, and associated interfaces. The role requires strong technical writing, disciplined documentation practices, and the ability to translate technical system behavior into clear and defensible validation evidence.

Key Responsibilities

Automation System Validation

• •Develop and support lifecycle validation strategies for GMP automation systems, including DeltaV, process historians, SCADA platforms, PLC controls, batch applications, and supporting infrastructure.
• •Define the appropriate validation deliverables based on intended use, system complexity, configuration, product or process impact, and risk.
• •Support new system implementations, expansions, upgrades, migrations, security updates, patches, and decommissioning activities.
• •Evaluate automation changes for validation impact and determine the testing, documentation, and approval requirements needed before release.
• •Help ensure validated systems remain fit for intended use throughout their operational lifecycle.
• •Support the transition of new or modified systems from project delivery into site operations and ongoing system ownership.

Lifecycle Documentation

• •Author, review, revise, and maintain validation and engineering documents, which may include: Validation plans and system validation plansUser requirements and functional requirementsFunctional and configuration specificationsSystem and data flow descriptionsRisk assessmentsRequirements traceability matricesCommissioning and qualification protocolsIQ, OQ, and PQ protocolsAutomation functional test scriptsValidation discrepancy and deviation recordsValidation summary reportsStandard operating procedures and work instructions
• •Confirm that requirements are clear, testable, traceable, and appropriate for the system’s intended use.
• •Ensure executed documentation is complete, legible, attributable, technically accurate, and consistent with site procedures.
• •Route documents through applicable document management and electronic quality management systems.
• •Work with reviewers and approvers to resolve comments efficiently while preserving technical and compliance integrity.

Testing and Qualification

• •Plan, coordinate, witness, or execute FAT, SAT, commissioning, qualification, regression, and functional testing for automation systems.
• •Verify control system functions such as sequences, phases, recipes, interlocks, alarms, permissives, calculations, interfaces, security roles, electronic records, and exception handling when applicable.
• •Record objective evidence demonstrating that systems and configured functions meet approved requirements.
• •Identify and document test exceptions, discrepancies, and unexpected results in accordance with established procedures.
• •Support troubleshooting and retesting activities with automation engineers, system integrators, vendors, and process subject matter experts.
• •Assist in determining the impact of test failures and confirm that corrective actions are completed before final acceptance.
• •Coordinate validation execution with project schedules, manufacturing availability, shutdown periods, and operational readiness milestones.

Risk-Based Assurance and Data Integrity

• •Apply risk-based validation principles consistent with applicable regulations, company procedures, and recognized industry practices.
• •Facilitate or contribute to system risk assessments, functional risk assessments, data integrity assessments, and validation impact assessments.
• •Use critical thinking to scale testing rigor and documentation depth according to intended use, patient or product risk, process criticality, and system complexity.
• •Evaluate GMP data flows, interfaces, calculations, records, and reporting functions for completeness and integrity.
• •Support assessments of audit trails, electronic signatures, access controls, account management, backup and recovery, time synchronization, and record retention where applicable.
• •Help ensure automation records support ALCOA+ data integrity principles.
• •Participate in periodic reviews and other activities used to confirm the continued validated state of GMP systems.

Change Control and Quality System Support

• •Provide automation and CSV input to change controls, deviations, CAPAs, investigations, and system lifecycle records.
• •Assess proposed configuration, hardware, software, infrastructure, recipe, interface, and security changes for GMP and validation impact.
• •Support root cause investigations for automation-related events and documentation discrepancies.
• •Define or review corrective actions, remediation testing, and effectiveness checks when required.
• •Monitor validation commitments and communicate risks that could affect project delivery, manufacturing readiness, or system release.
• •Contribute to inspection readiness, internal audits, client audits, and regulatory inspection support.
• •Retrieve and explain validation evidence to auditors, inspectors, and quality representatives as needed.

Cross-Functional Delivery

• •Partner with Automation, QA, IT, Engineering, Manufacturing, Validation, and system owners to align technical execution with quality requirements.
• •Gather and clarify system requirements with process owners, operators, engineers, and technical SMEs.
• •Participate in design reviews, project meetings, change review boards, risk workshops, deviation investigations, and release readiness discussions.
• •Review vendor and system integrator documentation for technical adequacy, traceability, and suitability for use as validation evidence.
• •Coordinate vendor testing and ensure supplier documentation is appropriately assessed before acceptance.
• •Communicate validation status, open issues, decisions, and schedule risks to project and functional stakeholders.
• •Promote consistent validation practices across automation projects and operational support activities.

Operational and Lifecycle Support

• •Review automation configurations and supporting infrastructure for compliance and validation impact.
• •Support u