Principal CSV Engineer - Automation Engineering

Lilly • Indianapolis, IN

2d • $67,500 - $173,800

About The Position

The Principal CSV Engineer will work in Eli Lilly’s Automation Engineering Department at the Lilly Medicine Foundry, providing technical subject-matter expertise and leadership for computer system validation (CSV) of process automation systems across the site and/or capital projects. The role supports reliable, compliant control applications and systems for manufacturing operations and works with cross-functional teams to validate systems critical to manufacturing medicines.

The Foundry is a new center for advanced manufacturing and drug development, combining research and manufacturing in one location. During project delivery and startup, expected from 2025 to 2028, the role will contribute to project delivery, formation of a new organization, and development and implementation of systems and business processes for GMP operations. Work will involve significant collaboration, creativity, and resilience as the site grows toward full-scale GMP manufacturing.

The engineer leads CSV strategy and execution, including risk assessments, validation plans and protocols, documentation, change control, deviation management, and maintenance of validated systems. The role also provides automation support and technical leadership for capital projects, new product introductions, design reviews, electronic production-data systems, and compliance activities. The initial work location is Carmel, Indiana, with a permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Requirements

• Minimum B.S. in Engineering or a related degree.
• At least 5 years of working experience for the Principal Engineer level; the posting also specifies a minimum of 8+ years for the Senior Principal level.
• Working experience in Biopharma Automation Engineering, preferably in major pharmaceutical manufacturing.
• Experience with the design, development, commissioning, or qualification of computer systems.
• Strong knowledge of GMP, regulatory requirements, and computer system validation.
• Strong planning and organizational skills, ability to prioritize tasks, and commitment to completing work on schedule.
• Strong problem-solving skills, technical curiosity, and commitment to continuous improvement.
• Ability to influence peers and business partners and provide technical leadership across cross-functional teams.
• Strong written and verbal communication skills for technical and non-technical audiences.

Nice To Haves

• Deep knowledge of GMP/GXP, regulatory requirements, computer system validation, and data integrity.
• Experience in Automation Engineering, preferably in major pharmaceutical manufacturing.
• Experience designing, developing, commissioning, and qualifying highly automated greenfield manufacturing sites using SCADA, DCS, MES, LIMS, and site historian systems such as DeltaV, Rockwell, Syncade, LabVantage, and OSI PI.
• Experience commissioning, qualifying, and supporting interconnectivity between SCADA, DCS, MES, LIMS, historians, and other applications.
• Experience in design, development, commissioning, and qualification activities that ensure quality compliance and data integrity.
• Experience facilitating and driving decision-making at an organizational level.

Responsibilities

• Lead process control validation testing, implementation, and coordination.
• Lead development and implementation of the Automation Engineering Project Validation Plan.
• Serve as a subject matter expert for computer system validation and data integrity for site automation systems, including DCS, SCADA, BMS, MES, historians, vendor-packaged equipment, automated storage and retrieval systems, and QMS.
• Lead computerized-system risk assessments and develop strategies to mitigate identified risks.
• Lead development and execution of validation protocols for computerized systems.
• Ensure compliance with regulatory requirements, industry standards, and Lilly quality policies and procedures.
• Lead generation and maintenance of validation documentation, including validation plans and summary reports.
• Develop local site procedures, such as SOPs and work instructions, related to automation systems.
• Provide technical leadership for change control and deviation management related to CSV activities.
• Collaborate with vendors to ensure third-party systems and software meet validation requirements, and conduct vendor audits as needed.
• Provide training and technical guidance on CSV principles, procedures, and best practices.
• Monitor industry trends and advances in CSV and automation technologies and advise on their application.
• Represent the Automation Department as a technical subject matter expert during assigned regulatory agency audits.
• Act as functional owner for the electronic testing system (Kneat, ALM, or ValGenesis), managing CSV documentation related to automation systems.
• Lead review and oversight of design documentation, including functional requirements, design specifications, DCS application software, test specifications, and execution.
• Lead or participate in design and automation application software reviews to support compliance and standardization.
• Provide periodic status updates to Project Management.
• Develop CSV and quality strategies for control systems in collaboration with Site Quality.
• Implement and support electronic systems, such as plant historians, that capture process-automation production data.
• Provide technical leadership to maintain validated site control systems in accordance with Lilly quality standards, including validation strategies and documentation.
• Provide automation support and technical leadership for capital projects, including new product introductions.
• Promote automation to improve productivity, operational efficiency, and compliance.
• Develop a network of corporate contacts and leverage corporate expertise when needed.
• Coordinate with automation and compliance consultants to establish and reinforce appropriate rigor standards for automation work products.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal