Job Title: Automation CSV Engineer

Location: Redmond, WA

Department: Global MSAT

The Role: / your challenge, ...in our journey

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.

Position Requirements

• 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.

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 (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.

The base pay range for this position at commencement of employment is expected to be $115,000 to $126,500; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.