CSV Engineer - Automation Engineering

Responsibilities

• 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, 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. 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 document relating to automation systems
• Operational Excellence Review and oversee the 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
• Automation support for capital projects including new product introductions
• Promote the use of automation to improve productivity, operational efficiency and compliance
• Develop a ‘network’ of corporate contacts and leveraging corporate expertise when needed

Requirements

• Minimum B.S. in Engineering or similar degree (Ph.D's will not be considered at this level)
• 2+ years working experience in FDA regulated environments
• Experience with design, development, commissioning, or qualification of computer systems