Principal Automation Engineer – Computer System Validation

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 40,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly is building a next-generation biotech drug substance manufacturing facility in Richmond, VA-our most technically advanced site to date. This greenfield facility will feature cutting-edge manufacturing technologies and advanced data platforms designed to drive improvements in safety, quality, and productivity. This is a rare opportunity to shape an organization, a facility, and a culture from the ground up.

Responsibilities:

The Principal Automation Engineer - Computer System Validation is a mid-level automation engineering position that requires a deep understanding of process automation systems, Lilly’s computer system validation practices, cGMP standards related to computer systems, and data integrity as they relate to pharmaceutical manufacturing.

This role will support the design and delivery of process automation systems including requirements, verification plans, validation plans, and strategies for overall computer system validation.

This role will also be integral in the development of computer system validation plans for process automation systems (DCS and PLC based), Building Management Systems, and supporting systems including data historians and other central automation platforms.

During the design and delivery (startup activities expected 2029 to 2030) of the project this role will be integrated into the corporate automation team GPACE (Global Process Automation & Control Engineering) and then transition fully to a site-based process team position. During delivery, this role will collaborate with Lilly Quality, A&E firms, system integrators, and corporate and site engineering peers.

Post-project delivery, this role will support GMP manufacturing operations in the central engineering function supporting one or more process teams. This role will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing site through start up.

Key Deliverables:

• Champion a strong safety culture, mentor and coach others, and utilize engineering and automation fundamental principles in design and problem solving.

• Become a subject matter expert on Lilly Quality Standards & Procedures that apply to Process Automation systems including requirements, design, and testing with a focus on the API / Drug Substance network

• Collaborate with Lilly’s Quality organization, Corporate Engineering, and Global Facilities Delivery to develop Computer System and Process Automation qualification and testing strategies.

• Lead and direct a contingent workforce team to support multiple project delivery workstreams on computer system validation. Ensure CSV documents comply with Corporate Quality Standards and Practices, local templates, and electronic document management system properties.

• Participate in basic and detailed design that also includes staffing, statements of work, supplier management, and delivery strategies computer system validation.

• Develop and build capabilities within the Richmond site automation team.

• Support the development of site procedures related to computer system validation and administration practices.

• Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose.

Basic Qualifications:

• Bachelor’s degree in engineering or related applicable discipline required.

• 3+ years of experience in computer system validation, process automation, and manufacturing.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• 3+ years of experience in pharmaceutical manufacturing preferred.
• 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 similar package.

• Ability to collaborate with others.

Additional Information:

• Potential for travel (less than 20% - could be domestic and/or international) to support system, factory acceptance testing, and training.

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Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.