Principal - Engineer - Automation; Computer System Validation

Position: Principal - Engineer - Automation (Computer System Validation)
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 - 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 work streams 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…