Principal Automation Engineer - Computer System Validation

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.
• 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.
• 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 $67,500 - $173,800 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. #WeAreLilly