> Markdown version of [/jobs/ext/2015560-automation-csv-engineer](https://www.wearedevelopers.com/jobs/ext/2015560-automation-csv-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Automation CSV Engineer - **Company:** Evotec - **Location:** Redmond, WA, United States - **Experience:** Expert - **Salary:** $115,000.0 - $126,500.0 - **Contract:** Permanent contract - **Skills:** Data Analysis, Audit Trail, Automation of Tests, Information Systems, Data Integrity, Document Management Systems, Supervisory Control and Data Acquisition (SCADA), Systems Analysis, Local Security Policy, Automation of Marketing, Systems Development Life Cycle, Requirements Management, Service Pack, Software Engineering, Software Requirements Analysis, System Testing, Systems Integration, Test Execution Engine, Iq/oq/pq, Computer Networking Systems, Test Scripts, Reliability of Systems, Information Technology, GXP - **Published:** August 10, 2026 - **Apply:** https://www.careerbuilder.com/job-details/automation-csv-engineer-site-based-redmond-wa-redmond-wa--ca19699f-7450-42f1-9f41-a6f79d446d96 ## About the Role * Bachelor's degree in Engineering, Computer Science, Biotechnology, Information Systems, or related technical discipline preferred. * Minimum of 5 years of experience supporting GMP automation systems, computer system validation (CSV), automation testing, or technical writing activities within regulated industries. * Hands-on experience with automation platforms such as DeltaV, PI, SCADA, PLC, or related manufacturing systems. * Experience executing validation and qualification activities including FAT, SAT, IQ, OQ, PQ, and functional testing. * Strong technical writing skills with experience authoring validation documentation and compliance records. * Working knowledge of GxP regulations and industry guidance including: 21 CFR Part 11 Annex 11 GAMP 5 FDA CSA principles Data Integrity requirements * Understanding of automation system lifecycle management and pharmaceutical quality systems. * Experience supporting change controls, deviations, CAPAs, and risk assessments within GMP environments. * Strong organizational skills and attention to detail with the ability to manage multiple assignments simultaneously. * Effective communication and collaboration skills with the ability to work across technical and business functions., * Experience supporting pharmaceutical, biotechnology, cell therapy, gene therapy, or medical device manufacturing operations. * Familiarity with MES, historians, batch systems, or manufacturing data systems. * Exposure to electronic quality management systems (eQMS), document management systems, and change management processes. * Experience supporting regulatory inspections or internal audits. * Understanding of SDLC methodologies and risk-based validation practices. * Knowledge of networking, system interfaces, or industrial automation infrastructure concepts. * Experience working with system integrators, vendors, or third-party validation providers. Travel & Work Flexibility * Occasional travel to manufacturing or project sites may be required. * Flexibility in working hours may be needed during validation execution, project support activities, or manufacturing shutdown windows., Automation, Automation Systems, Best Practices, Biotech and Pharmaceutical, Change Control, Change Management, Code of Federal Regulations, Commissioning, Communication Skills, Computer Science, Computer Systems, Continuous Improvement, Corrective Action, Cross-Functional, Data Analysis, Data Quality, DeltaV, Detail Oriented, Discrepancy Report, Document Change Management, Documentation Review, FDA (Food and Drug Administration), Functional Testing, GMP (Good Manufacturing Practices), Gene Therapy, GxP, Identify Issues, Industry Standards, Information Technology & Information Systems, Internal Audit, Leading Edge Technology, Manufacturing, Manufacturing Automation, Manufacturing Operations, Manufacturing Systems, Medical Equipment, Mentoring, Network Systems, Organizational Skills, Process Control Engineering, Process Validation, Programmable Logic Controller (PLC), Quality Assurance, Quality Assurance Methodology, Quality Management, Quality Metrics, Regulations, Requirements Management, Risk, Risk Analysis, Risk Management, Software Development Lifecycle (SDLC), Software Patches, Standard Operating Procedures (SOP), Supervisory Control and Data Acquisition (SCADA), Support Documentation, System Integration (SI), System Lifecycle, System Validation, Systems Administration/Management, Systems Analysis, Systems Reliability, Team Player, Technical Support, Technical Writing, Test Automation, Test Scripts, Testing, Traceability, Validation Documentation, Validation Plan, Validation Testing, Willing to Travel, Writing Skills ## Description 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 ideal candidate will have experience supporting automation validation and Computer System Validation (CSV) activities for manufacturing systems such as DeltaV, PI, SCADA, PLC, and related automation platforms. 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. What You'll Do: Automation Validation & Compliance Support * 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. Validation Documentation & Technical Writing * 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. Testing & Execution Support * 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, ITCSV, Validation, and system owners to support project timelines and operational readiness. * Assist with troubleshooting issues identified during testing and support resolution activities. Cross-Functional Collaboration * Serve as a liaison between QA, Automation, ITCSV, 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. Risk-Based Validation & Quality Systems * 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. Automation System Support * Assist in reviewing automation system configurations, interfaces, alarms, security settings, and process control functionality for compliance and validation impact. * Support data integrity assessments, user access reviews, backup verification, and audit trail review activities where applicable. * Work with Automation and IT teams to support system reliability, compliance, and operational continuity. * Maintain awareness of current regulatory guidance and industry best practices related to CSV and automation validation. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Resilient by Design: Building Robust Architectures in High-Stakes Financial Systems](https://www.wearedevelopers.com/videos/2106-resilient-by-design-building-robust-architectures-in-high-stakes-financial-systems) - [Remote Driving on Plant Grounds with State-of-the-Art Cloud Technologies](https://www.wearedevelopers.com/videos/251-remote-driving-on-plant-grounds-with-state-of-the-art-cloud-technologies) - [Enabling automated 1-click customer deployments with built-in quality and security](https://www.wearedevelopers.com/videos/83-enabling-automated-1-click-customer-deployments-with-built-in-quality-and-security) - [No Keys for the Robot: GitOps as the Control Plane for Autonomous Agents](https://www.wearedevelopers.com/videos/100095-no-keys-for-the-robot-gitops-as-the-control-plane-for-autonomous-agents) - [How One Developer Built the Back Office for 10 Million Companies](https://www.wearedevelopers.com/videos/100082-how-one-developer-built-the-back-office-for-10-million-companies) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Quick guide: How to write a Software Developer CV](https://www.wearedevelopers.com/magazine/37-quick-guide-how-to-write-a-software-developer-cv) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated)