Principal CSV Engineer - Automation Engineering

Organization and Position Overview

This role will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will serve as a technical subject matter expert, providing automation support for one or more operating areas across the site and/or for capital projects. This role will provide technical leadership for CSV, leading and executing CSV activities for process automation systems across the site.

The engineer will collaborate with cross-functional teams and provide technical expertise and direction in validating systems critical to the manufacture of life-changing products at the new site. The Engineer is also responsible for ensuring that reliable and compliant control applications and systems are in place and maintained to support manufacturing operations at the Foundry.

Responsibilities

• Lead process control validation testing, implementation, and coordination.
• Lead the development and implementation of the Automation Engineering Project Validation Plan.
• Serve as a subject matter expert 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.
• Lead and perform risk assessments for computerized systems and develop strategies to mitigate identified risks.
• Lead the development and execution of 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.
• Lead the generation and maintenance of validation documentation, such as validation plans and summary reports.
• Develop local site procedures (e.g., SOPs, Work Instructions, etc.) related to automation systems.
• Provide technical leadership for 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 and technical guidance to personnel on CSV principles, procedures, and best practices.
• Stay informed of industry trends (e.g., CSA) and advancements in CSV and automation technologies and provide subject matter expertise regarding their application.
• Represent the Automation Department as a technical subject matter expert during audits by regulatory agencies as assigned.
• Act as functional owner for the electronic testing system (Kneat, ALM, ValGenesis), managing CSV documentation relating to automation systems.

Operational Excellence

• Lead the review and oversight of 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.
• Lead the development of CSV and quality strategies for control systems in collaboration with the Site Quality organization.
• Implement and support electronic systems (such as plant historians) used to capture process automation-related production data.
• Provide technical leadership to 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.
• Provide Automation support and technical leadership 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 leverage corporate expertise when needed.

Organizational Capability

• In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.
• Demonstrated initiative, strong planning and organizational skills, ability to prioritize tasks, and commitment to task completion and timelines.
• Possess a keen technical curiosity and demonstrate strong problem-solving skills and a desire for continuous improvement.
• Demonstrated ability to influence peers and business partners and provide technical leadership across cross-functional teams.
• Strong written and verbal communication skills for both technical and non-technical audiences.
• Strong knowledge of GMP, regulatory requirements, and computer system validation.

Basic Requirements

• Minimum B.S. in Engineering or related degree and a minimum of 5 years (at the Principal Engineer level) and a minimum of 8+ years' experience (at the Senior Principal level) working experience in Biopharma Automation Engineering, preferably in major pharmaceutical manufacturing.
• Experience with design, development, commissioning, or qualification of computer systems.

Additional Preferences

• Deep knowledge of GMP/GXP, regulatory requirements, computer system validation, and data integrity.
• Experience in Automation Engineering, preferably in major pharmaceutical manufacturing.
• Experience in design, development, commissioning, and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI).
• Experience in commissioning, qualifying, and supporting systems between SCADA, DCS, MES, LIMS, Historian, and other applications for interconnectivity.
• Experience in design, development, commissioning, and qualification activities ensuring quality compliance and data integrity.
• Experience in facilitating and driving decision-making at an organizational level.

Other Information

Initial location in Carmel, IN. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.