CSV Engineer - Automation Engineering

About This Role

This role is for a CSV Engineer in the Automation Engineering Department at Eli Lilly's new Medicine Foundry. The engineer will provide automation support for operating areas and capital projects, leading and executing CSV activities for process automation systems. This involves collaborating with cross-functional teams to validate systems critical to manufacturing life-changing products at the new site.

Responsibilities

• Perform process control validation testing, implementation, and coordination
• Develop and implement the Automation Engineering Project Validation Plan
• Provide subject matter expertise for computer system validation and data integrity for automation systems across the site, including Process Automation Systems (DCS, SCADA, BMS, MES, Historian), Building Management System, Vendor Packaged Equipment, Data Historian, Automated Storage and Retrieval System, and QMS
• Perform risk assessments for computerized systems and develop strategies to mitigate identified risks
• Develop and execute validation protocols for computerized systems
• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity, etc.) and corporate Lilly quality policies and procedures
• Generate and maintain validation documentation, such as validation plans and summary reports
• Develop local site procedures (e.g., SOPs, Work Instructions, etc.) related to automation systems
• Manage change control and deviation management as it pertains to CSV activities
• Collaborate with vendors to ensure that third-party systems and software meet validation requirements and conduct vendor audits as needed
• Provide training to personnel on CSV principles, procedures, and best practices
• Stay informed of industry trends (e.g., CSA) and advancements in CSV and automation technologies
• Represent the automation department during audits by regulatory agencies as assigned
• Act as functional owner for the Electronic testing system (Kneat, ALM, Valgenesis), managing CSV documents relating to automation systems
• Review and oversee Design documentation including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications, and execution
• Lead/participate in design reviews and Automation application software reviews to ensure compliance and standardization
• Provide periodic status updates to Project Management
• Devise CSV and quality strategies for control systems in collaboration with Site Quality organization
• Implement and support electronic systems (such as plant historians) used to capture process automation related production data
• Maintain the validated state of the site control systems in line with Lilly quality standards, including the development and execution of validation strategies and associated documentation