Principal - Engineer - Automation (Computer System Validation)
Eli Lilly and Company
6 months ago
On-site
Houston, TX
IT
Responsibilities:
- Support the design and delivery of process automation systems, including requirements, verification plans, validation plans, and strategies for overall computer system validation.
- Develop computer system validation plans for process automation systems (DCS/PLC), Building Management Systems, data historians, and other central automation platforms.
- Collaborate with Lilly Quality, A&E firms, system integrators, and engineering peers; transition from corporate automation team involvement to site-based process teams.
- Support GMP manufacturing operations post-project in a central engineering function supporting one or more process teams.
- Champion a strong safety culture; mentor and coach others.
- Become a subject matter expert on Lilly Quality Standards & Procedures for Process Automation systems (requirements, design, testing) for the API/Drug Substance network.
- Collaborate to develop Computer System and Process Automation qualification and testing strategies.
- Lead and direct a contingent workforce team for computer system validation; ensure CSV documents comply with corporate standards, local templates, and electronic document management system properties.
- Participate in basic and detailed design including staffing, statements of work, supplier management, and delivery strategies.
- Develop and build capabilities within the Houston site automation team.
- Support development of site procedures for computer system validation and administration practices.
- Provide technical oversight for equipment and process system User Requirements and Design Review/Qualification documentation.
Key Deliverables:
- Safety culture leadership; SME for quality/CSV; qualification/testing strategy development; contingent workforce leadership; design participation; site procedure support; technical oversight.
Basic Qualifications:
- Bachelor’s degree in engineering or related applicable Science degree (required).
- 3+ years’ experience in computer system validation.
- 3+ years’ experience in process automation.
- 3+ years’ experience in pharmaceutical manufacturing (Food & Beverage and Nuclear experience also considered).
Additional Skills/Preferences:
- Experience with Rockwell Automation and Emerson DeltaV.
- Strong analytical, writing, and critical thinking skills.
- Experience with Kneat Validation software and/or Veeva Vault or similar.
- Ability to collaborate with others.
Additional Information:
- Travel potential (<20%) to support system and factory acceptance testing and training.
Benefits (explicitly stated):
- Eligible for a company bonus (depending on company and individual performance) and comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription drug benefits, flexible benefits, life insurance/death benefits, certain time off and leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Compensation (explicitly stated):
- Anticipated wage: $66,000 - $171,600.
Application Instructions (explicitly stated):
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Support the design and delivery of process automation systems, including requirements, verification plans, validation plans, and strategies for overall computer system validation.
- Develop computer system validation plans for process automation systems (DCS/PLC), Building Management Systems, data historians, and other central automation platforms.
- Collaborate with Lilly Quality, A&E firms, system integrators, and engineering peers; transition from corporate automation team involvement to site-based process teams.
- Support GMP manufacturing operations post-project in a central engineering function supporting one or more process teams.
- Champion a strong safety culture; mentor and coach others.
- Become a subject matter expert on Lilly Quality Standards & Procedures for Process Automation systems (requirements, design, testing) for the API/Drug Substance network.
- Collaborate to develop Computer System and Process Automation qualification and testing strategies.
- Lead and direct a contingent workforce team for computer system validation; ensure CSV documents comply with corporate standards, local templates, and electronic document management system properties.
- Participate in basic and detailed design including staffing, statements of work, supplier management, and delivery strategies.
- Develop and build capabilities within the Houston site automation team.
- Support development of site procedures for computer system validation and administration practices.
- Provide technical oversight for equipment and process system User Requirements and Design Review/Qualification documentation.
Key Deliverables:
- Safety culture leadership; SME for quality/CSV; qualification/testing strategy development; contingent workforce leadership; design participation; site procedure support; technical oversight.
Basic Qualifications:
- Bachelor’s degree in engineering or related applicable Science degree (required).
- 3+ years’ experience in computer system validation.
- 3+ years’ experience in process automation.
- 3+ years’ experience in pharmaceutical manufacturing (Food & Beverage and Nuclear experience also considered).
Additional Skills/Preferences:
- Experience with Rockwell Automation and Emerson DeltaV.
- Strong analytical, writing, and critical thinking skills.
- Experience with Kneat Validation software and/or Veeva Vault or similar.
- Ability to collaborate with others.
Additional Information:
- Travel potential (<20%) to support system and factory acceptance testing and training.
Benefits (explicitly stated):
- Eligible for a company bonus (depending on company and individual performance) and comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription drug benefits, flexible benefits, life insurance/death benefits, certain time off and leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Compensation (explicitly stated):
- Anticipated wage: $66,000 - $171,600.
Application Instructions (explicitly stated):
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation