Computer System Validation Jobs in Houston, TX (NOW HIRING)

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.

The Sr. Principal Automation Engineer – Small Molecule is a senior automation position that will lead the design and delivery of the DeltaV platform and associated software integration teams as part of Lilly’s manufacturing expansion. This role is intended to lead one or more project workstreams for the automation DCS function including design, scheduling, staffing, and qualification in the Drug Substance (Active Pharmaceutical Ingredient) network.

During the design and delivery (startup expected 2029 to 2030) of the project this role will be integrated into the corporate delivery team leading one or more workstreams on the design, delivery, and startup of drug substance manufacturing focusing on Small Molecule. This role will collaborate with A&E firms, system integrators, corporate and site engineering peers, and Tech@Lilly (Lilly’s corporate IT team) develop and manage the DeltaV DCS system and software design, testing, startup, and qualification.

The Sr. Principal Automation Engineer is a site-based position but will be closely integrated with Lilly’s Corporate Automation Team GPACE. GPACE (Global Process Automation & Control Engineering) provides automation, measurement, and process control solutions to Lilly manufacturing as well as a technical resource for training, standards, and capital project delivery.

Post project delivery, this role will support GMP manufacturing operations in small molecule or oligonucleotides. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

• Champion a strong safety culture, mentor and coach others, and utilize engineering and automation fundamental principles in design and problem solving.
• Collaborate with Lilly engineering, A&E firms, and system integrators to develop requirements and specifications that will be the foundation for software development and system architecture.
• Manage one or more system integrators for fully deliver and test DeltaV software.
• Collaborate with Tech@Lilly to deliver a fully integrated Automation/MES solution that is scaled for the needs of business.
• Participate in basic and detailed design that also includes staffing, statements of work, supplier management, and delivery strategies for automation systems.
• Participate in developing computer system validation strategies.
• Develop and build capabilities within the Houston site automation team.
• Develop site procedures for automation platforms and associated administration activites.
• Provide engineering support for Process Safety Management (PSM) and Process Hazard Reviews (PHRs).
• 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.

• Bachelor’s degree in engineering or related applicable discipline required.
• 5+ years of experience Process Automation with experience on the Emerson DeltaV Platform preferred. Other platform experience will be considered.
• 5+ years of experience in API/Drug Substance manufacturing preferred. Related manufacturing experience will be considered.
• 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.

• Technical knowledge in process instrumentation.
• Batch control.
• Strong analytical and critical thinking skills.
• Ability to collaborate with others.
• Ability to influence.
• Technical knowledge on the utilization of data historians.
• Experience with system integration including MES.

• Potential for travel (less than 20% - could be domestic and/or international).

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.

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.