Computer System Validation Manager Jobs in Texas

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 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.
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 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 [MH1] 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 - Data and Integration Platforms is a mid-level automation engineering position that requires a deep understanding of process data historians, system integration, 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 site data historian system, key integration platforms, and the system administration of site servers.
This role will also be integral in the design and delivery of data historian and integration platforms including design, validation plans, system integrator selection and oversight, and developing the site administrative procedures that ensure they remain in a validated state. This role will also support, as a secondary responsibility, related site automation platforms including process automation servers and the DeltaV DCS. 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, Emerson, and corporate and site engineering peers.
Post-project delivery, this role will support GMP manufacturing operations in the central engineering function supporting site process teams with Data Historian and integration services as well as system administration and platform upgrades. 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's Aveva PI Data Historian reference architecture.
• Support the design, delivery, validation, and system management of the site Data Historian and related system integration platforms.
• Lead and direct system integrations and OEM's on the design and installation of the Aveva PI platforms, data centers, and associated site infrastructure.
• Collaborate with Lilly's Quality organization, Corporate Engineering, and Global Facilities Delivery to develop Computer System qualification and testing strategies.
• 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 discipline required.
• 3+ years of experience in Aveva PI Data Historian administration including hardware design, software integration, and system procedures.
• Experience with Windows Servers and virtual environments.
• 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. Other manufacturing experience will be considered.
• 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.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
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.
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