Senior Automation Engineer: CSV & Pharma Systems

Eli Lilly and Company; Richmond (VA); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Job summary

Lilly is building a next-generation biotech drug substance manufacturing facility in Richmond, VA. The Principal Automation Engineer – Computer System Validation will help design, deploy, and validate process automation systems (DCS/PLC) to meet cGMP standards with data integrity at the core.

You will lead validation strategy development, collaborate with Quality and Engineering, and guide a contingent workforce through delivery and startup activities toward scaled GMP operations at the site.

Qualifications

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

Responsibilities

• 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.

Skills

Process automation

Computer system validation

Manufacturing

Education

Bachelor’s degree in engineering or related discipline

Tools

Rockwell Automation

Emerson DeltaV

Kneat Validation

Veeva Vault

Job description

Lilly is building a next-generation biotech drug substance manufacturing facility in Richmond, VA. The Principal Automation Engineer – Computer System Validation will help design, deploy, and validate process automation systems (DCS/PLC) to meet cGMP standards with data integrity at the core.

You will lead validation strategy development, collaborate with Quality and Engineering, and guide a contingent workforce through delivery and startup activities toward scaled GMP operations at the site.