Computer System Validation Csv Pharmaceutical Jobs in Texas

The Principal Automation Engineer – DeltaV System Administrator is an mid-level automation engineering position that requires a deep understanding of process automation systems (DeltaV), 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 for the site Emerson DeltaV DCS platforms.

This role will also be integral in the hardware design of the site DeltaV DCS platform, creating site administrative procedures, and validation of the systems. This role will also support, as a secondary responsibility, related site automation platforms including Data Historians and process automation servers. 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 DeltaV system administration services 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.

• 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 DeltaV reference architecture to create a site design for the DeltaV platform.
• Support the design, delivery, validation, and system management of the site DeltaV platforms.
• Lead and direct system integrations and OEM’s on the design and installation of the DeltaV 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 for 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.

• Bachelor’s degree in engineering or related Science Degree required.
• 3+ years of experience in Emerson DeltaV system administration including hardware design.
• Experience with Windows Servers and virtual environments.
• Experience in process automation.
• 3+ years of experience in pharmaceutical manufacturing. Other 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.

• Strong analytical, writing, and critical thinking skills.
• Experience with Kneat Validation software, Veeva Vault, or similar package.
• Ability to collaborate with others.

• 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.

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.