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# Automation CSV Engineer - GMP / DeltaV

- **Company:** Algoworks Solutions, Inc.
- **Location:** Kirkland, WA, United States
- **Experience:** Expert
- **Salary:** $104,000.0 - $145,600.0
- **Contract:** Temporary to permanent
- **Skills:** Configuration Management, Information Systems, Databases, Data Integrity, Middleware, Electronic Signatures, Supervisory Control and Data Acquisition (SCADA), OLE for Process Control, Regression Testing, System Testing, Technical Data Management Systems, Iq/oq/pq, Test Scripts, Computerised Systems, Information Technology, Tools for Reporting, GXP
- **Published:** October 14, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=f79269b795af382c

## About the Role

The ideal candidate will have hands-on experience with automation validation, Computerized System Validation (CSV), and qualification activities, preferably within pharmaceutical, biotechnology, or other regulated manufacturing environments., * Bachelor's degree in Engineering, Computer Science, Information Systems, Biotechnology, Life Sciences, or a related discipline, or equivalent relevant experience.

 * 5+ years of experience in automation validation, Computerized System Validation (CSV), commissioning and qualification, or automation engineering in a regulated environment.
 * Hands-on experience with one or more technologies such as Emerson DeltaV, AVEVA/OSIsoft PI System, SCADA, PLC/HMI, batch control systems, or manufacturing data applications.
 * Experience preparing and executing validation deliverables, including FAT, SAT, IQ, OQ, PQ, regression testing, or automation functional testing.
 * Strong technical writing and documentation skills.
 * Working knowledge of GMP, FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and ALCOA+ data integrity principles.
 * Experience with quality systems, including change control, deviations, CAPA, risk management, and investigations.
 * Understanding of automation system architecture, interfaces, configuration management, and system lifecycle controls.
 * Strong communication, analytical, organizational, and stakeholder management skills., * Direct experience validating or supporting Emerson DeltaV in a GMP manufacturing environment.
 * Experience in pharmaceutical, biotechnology, biologics, cell therapy, gene therapy, or medical device manufacturing.
 * Familiarity with MES, electronic batch records (EBR), process historians, laboratory systems, and manufacturing data platforms.
 * Knowledge of OPC, databases, middleware, reporting tools, industrial networks, and cybersecurity controls.
 * Experience supporting system upgrades, migrations, disaster recovery testing, audits, inspections, and supplier documentation reviews.
 * Experience working with automation system integrators, equipment vendors, or validation service providers.

Technologies and Compliance

Emerson DeltaV | AVEVA / OSIsoft PI | SCADA | PLC/HMI | Batch Control | MES/EBR | FDA 21 CFR Part 11 | EU GMP Annex 11 | GAMP 5 | ALCOA+ | FAT/SAT | IQ/OQ/PQ | Change Control | CAPA | Data Integrity

## Description

Algoworks is seeking an experienced Automation CSV Engineer to support validation, compliance, testing, and technical documentation for GMP automation and computerized systems in a regulated manufacturing environment., You will collaborate with Automation, Quality Assurance, IT/CSV, Manufacturing, Engineering, and Validation teams to ensure computerized systems remain compliant, reliable, and in a validated state throughout their lifecycle., * Develop and support lifecycle validation strategies for GMP automation systems, including Emerson DeltaV, SCADA, PLC/HMI, process historians, and batch control applications.

 * Prepare, review, and maintain validation documentation, including URS/FRS, risk assessments, RTMs, IQ/OQ/PQ protocols, test scripts, and validation summary reports.
 * Support system implementations, upgrades, migrations, patches, configuration changes, and decommissioning activities.
 * Plan, execute, coordinate, and document FAT, SAT, commissioning, qualification, regression, and functional testing.
 * Assess system and configuration changes for validation impact, testing requirements, documentation, and release readiness.
 * Verify automation functionality, including recipes, sequences, alarms, interlocks, interfaces, access controls, electronic records, and exception handling.
 * Investigate test deviations, support troubleshooting and retesting, and document corrective actions.
 * Support change controls, deviations, CAPAs, risk assessments, audits, regulatory inspections, and remediation activities.
 * Evaluate data integrity controls, audit trails, electronic signatures, backup and recovery, security roles, and record retention.
 * Collaborate with cross-functional teams, system owners, vendors, and system integrators to maintain compliance and continuous improvement.