Principal Automation Engineer – Computer System Validation

Lilly • Richmond, VA

7d • $67,500 - $173,800

About The Position

The Principal Automation Engineer – Computer System Validation is an automation engineering position focused on process automation systems, Lilly computer system validation practices, cGMP standards for computer systems, and data integrity in pharmaceutical manufacturing. The role supports the design and delivery of process automation systems, including requirements, verification plans, validation plans, and computer system validation strategies.

The position develops validation plans for DCS- and PLC-based process automation systems, Building Management Systems, data historians, and other central automation platforms. During project design and delivery, with startup activities expected in 2029–2030, the role will be part of Lilly’s corporate automation team, GPACE, and later transition to a site-based process team position. Project collaboration includes Lilly Quality, A&E firms, system integrators, and corporate and site engineering peers. After project delivery, the role supports GMP manufacturing operations in central engineering for one or more process teams.

The role will help establish and grow automation capabilities at Lilly’s next-generation biotech drug substance manufacturing facility in Richmond, Virginia. It requires collaboration, creativity, and resilience as the site develops into a full-scale GMP manufacturing operation.

Requirements

• Bachelor’s degree in engineering or a related applicable discipline.
• At least 3 years of experience in computer system validation, process automation, and manufacturing.
• Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas.

Nice To Haves

• At least 3 years of experience in pharmaceutical manufacturing.
• Experience with automation platforms including Rockwell Automation and Emerson DeltaV.
• Strong analytical, writing, and critical thinking skills.
• Experience with Kneat Validation software, Veeva Vault, or a similar package.
• Ability to collaborate with others.

Responsibilities

• Champion a strong safety culture, mentor and coach others, and apply engineering and automation fundamentals to design and problem solving.
• Become a subject matter expert on Lilly Quality Standards and Procedures applicable to process automation systems, including requirements, design, and testing, with a focus on the API / Drug Substance network.
• Collaborate with Lilly Quality, Corporate Engineering, and Global Facilities Delivery to develop computer system and process automation qualification and testing strategies.
• Lead and direct a contingent workforce team supporting multiple project delivery workstreams in computer system validation.
• Ensure computer system validation documents comply with Corporate Quality Standards and Practices, local templates, and electronic document management system properties.
• Participate in basic and detailed design, including staffing, statements of work, supplier management, and computer system validation delivery strategies.
• Develop and build capabilities within the Richmond site automation team.
• Support development of site procedures for computer system validation and administration practices.
• Provide technical oversight during development of equipment and process system User Requirements and related Design Review and Qualification documentation to ensure systems are appropriate for their intended purpose.
• Support GMP manufacturing operations in central engineering for one or more process teams after project delivery.

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