Automation CSV Engineer - Site Based, Redmond, WA

Cyprotex•Redmond, WA

48d•$115,000 - $126,500•Onsite

About The Position

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. 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.

Requirements

Bachelor’s degree in Engineering, Computer Science, Information Systems, Biotechnology, Life Sciences, or a related technical discipline, or an equivalent combination of education and relevant experience.
At least five years of experience in automation validation, computer system validation, commissioning and qualification, automation engineering, or computerized system quality within a regulated environment.
Working experience with one or more industrial automation technologies, such as: Emerson DeltaV, AVEVA PI System or OSIsoft PI, SCADA platforms, PLC and HMI systems, Batch control systems, Manufacturing data collection or reporting applications.
Experience creating and executing validation or qualification deliverables, including FAT, SAT, IQ, OQ, PQ, regression testing, or automation functional testing.
Demonstrated ability to author clear, technically accurate validation documentation.
Knowledge of GMP system lifecycle controls and applicable requirements or guidance, including: 21 CFR Part 11, EU GMP Annex 11, GAMP 5, Data integrity principles, Risk-based computerized system assurance practices.
Experience working within formal quality systems, including change control, deviations, CAPAs, and risk management.
Understanding of automation system architecture, interfaces, configuration management, and operational support.
Ability to manage multiple deliverables and priorities while maintaining documentation quality and schedule awareness.
Strong communication skills and the ability to work effectively with both technical and nontechnical stakeholders.

Nice To Haves

Direct experience validating or supporting Emerson DeltaV in a GMP manufacturing environment.
Experience with DeltaV batch configuration, phases, recipes, modules, alarms, interlocks, security, or system interfaces.
Experience in pharmaceutical, biotechnology, biologics, cell therapy, gene therapy, or medical device manufacturing.
Familiarity with MES, electronic batch records, process historians, laboratory systems, building automation systems, or manufacturing data platforms.
Experience with system integration involving OPC, databases, middleware, reporting tools, or industrial network infrastructure.
Familiarity with electronic document management systems, eQMS platforms, and electronic validation tools.
Experience supporting GMP system upgrades, migrations, disaster recovery testing, or cybersecurity remediation.
Knowledge of software development lifecycle and configuration management practices.
Experience reviewing vendor documentation and leveraging supplier testing or engineering records as validation evidence.
Previous participation in regulatory inspections, client audits, quality audits, or remediation programs.
Experience working with automation system integrators, equipment vendors, validation service providers, or managed service partners.

Responsibilities

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.
Author, review, revise, and maintain validation and engineering documents, which may include: Validation plans and system validation plans, User requirements and functional requirements, Functional and configuration specifications, System and data flow descriptions, Risk assessments, Requirements traceability matrices, Commissioning and qualification protocols, IQ, OQ, and PQ protocols, Automation functional test scripts, Validation discrepancy and deviation records, Validation summary reports, Standard 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.
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.
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.
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.
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.
Review automation configurations and supporting infrastructure for compliance and validation impact.
Support user access reviews, account recertification, backup verification, restore testing, audit trail review, and disaster recovery activities as assigned.
Assist with system health assessments, periodic reviews, lifecycle planning, and obsolescence evaluations.
Work with Automation and IT/OT teams to support system availability, cybersecurity controls, operational continuity, and controlled maintenance.
Develop or improve templates, test methods, procedures, and tools that increase validation efficiency without reducing assurance.
Maintain awareness of evolving regulatory expectations, automation technologies, and industry practices relevant to computerized systems.