Automation CSV Engineer - Site Based, Redmond, WA

Automation CSV Engineer Location: Redmond, WA Department: Global MSAT About Us: Evotec is a forward‑thinking team that thrives on challenging the status quo and encourages curiosity. We are committed to a diverse and inclusive environment where curiosity is celebrated. The Role The Automation CSV Engineer supports validation, compliance, testing, and technical documentation activities for GMP automation systems within a regulated manufacturing environment. Partnering closely with Automation, QA, IT CSV, Manufacturing, and Engineering teams, the engineer ensures automation systems remain compliant, reliable, and maintained in a validated state throughout the system lifecycle. What You’ll Do Automation Validation & Compliance Support Support validation and lifecycle management of 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. Participate in implementation, upgrade, patching, migration, and change control activities. 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 (Validation Plans, IQ/OQ/PQ Protocols, Test Scripts, Traceability Matrices, Functional Specifications, Discrepancy Reports, Summary Reports, SOPs, and Work Instructions). Ensure 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 per approved procedures. Coordinate testing activities with Automation, QA, IT CSV, 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, IT CSV, Engineering, and Manufacturing teams to align validation and compliance activities. Collaborate with system owners and technical SMEs to gather requirements and support risk assessments. Participate in project meetings, change control reviews, deviation investigations, and quality discussions related to automation systems. Support vendor and integrator coordination 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 activities for automation systems and computerized systems. Support periodic reviews, audit readiness activities, and inspection support. 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 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. Position Requirements Bachelor’s degree in Engineering, Computer Science, Biotechnology, Information Systems, or related discipline (preferred). Minimum of 5 years experience supporting GMP automation systems, computer system validation, automation testing, or technical writing in regulated industries. Hands‑on experience with 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 (21 CFR Part 11, Annex 11, GAMP 5, FDA CSA principles, Data Integrity). 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, ability to manage multiple assignments simultaneously. Effective communication and collaboration skills, able to work across technical and business functions. Preferred Qualifications 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, 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. Benefits Base pay range: $115,000 to $126,500 at commencement. Salary may vary based on skills, experience and market value. Discretionary annual bonus, comprehensive benefits (Medical, Dental, Vision), short‑term and long‑term disability, company‑paid basic life insurance, 401(k) company match, flexible work, generous paid time off, paid holidays, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status. #J-18808-Ljbffr Evotec