Automation CSV Engineer - GMP / DeltaV

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.

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

• This is an Hybrid - 3 days onsite per week in Redmond, Washington.
• Occasional travel to manufacturing, vendor, or project locations may be required.
• Flexibility may be needed during system upgrades, testing, shutdowns, qualification activities, and critical issue resolution.
• Work may involve manufacturing, laboratory, utility, or controlled production areas and compliance with applicable site safety and gowning requirements.

Pay: $50.00 - $70.00 per hour

Expected hours: 40.0 per week

Algoworks is an award-winning artificial intelligence, engineering services and experience transformation firm with offices across the United States, Europe, South America and India. We bring together a global team of engineers, architects, designers, researchers and operators united by rigor, accountability and a commitment to delivering measurable results.

For over 20 years, Algoworks has partnered with Fortune 500 organizations across the Americas, Europe and Asia to define, build and run technology that drives meaningful business outcomes. Our work combines human-centered design, engineering excellence and AI-powered capabilities to solve complex challenges with clarity and precision. Innovation, particularly in the responsible application of AI, is embedded in how teams approach problem-solving and continuous improvement.

At Algoworks, growth is continuous and closely tied to impact. Teams collaborate across geographies and disciplines, strengthening outcomes through shared insight and collective expertise. The culture values transparency, open dialogue and an environment where every voice is heard and contribution is recognized.

Through collaboration, accountability and a focus on results, Algoworks operates at the intersection of technology and people, building not only advanced systems but strong global teams that elevate performance and create lasting impact.