Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX.This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the site technical team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the processes, the facility and the culture to enable a successful startup into GMP manufacturing operations.
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. Lilly Houston is part of Lilly’s Drug Substance (Active Pharmaceutical Ingredient) network.
During the design and delivery 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 Houston 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 Science degree required.
- 3+ years of experience in computer system validation.
- 3+ years of experience in process automation.
- 3+ years of experience in pharmaceutical manufacturing. Other manufacturing experience will be considered (Food & Beverage and Nuclear).
Additional Skills/Preferences:
- 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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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.
