Sr. Engineer - CSV at Eli Lilly and Company

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.

Organization Overview

Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities.  This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Position Overview

As a Computer System Validation Engineer, you will play a pivotal role in ensuring compliance and integrity of computerized systems within our active pharmaceutical ingredient manufacturing facility. The CSV Engineer will work as a member of the Process Automation team at Eli Lilly, Lebanon. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will collaborate with cross-functional teams, providing expertise in validating systems critical to the manufacture of life changing products at the new site.

Responsibilities:

• Provide site engineering input to Commissioning and Qualification and Data Integrity programs.
• Review or develop Automation system Software Development Lifecyle (VP, URS, FRS, FS, DS, etc) documentation.
• Develop and execute Validation Plan, Validation Strategies, Trace Matrix, Test Protocols/Cases (IQ/IV, OQ/OV, PQ) and/or Test Scripts as applicable for DCS, PLC, DDC and PAT based systems.
• Perform periodic reviews on qualified/validated Automated Systems (Process Control and Automated Equipment).
• Lead and/or assist with remediation activities including potential Qualification/Validation activities to address identified process and equipment gaps.
• Identify Data Integrity gaps and propose/implement solutions.
• Develop and participate on community of practice for the site for Data Integrity and CSV programs.
• Evaluate new technologies for potential integration to ensure data integrity requirements are met.
• Execute and develop best practices and standards to support manufacturing and major capital project delivery.
• Work globally with other Lilly manufacturing sites to share best practices.
• Work safely and continually look for improvements to both people and equipment safety.

Basic Requirements:

• B.S. in Engineering, Computer Science, or related Science/Information Technology Field
• 3+ Years Experience leading and/or supporting Commissioning and Qualification strategies and tasks on Automated/Computerized manufacturing systems.
• 3+ Years of experience in one or more process automation platforms (DeltaV/Rockwell/ Johnsons Controls).
• 2+ Years of experience working in a cGMP regulated industry (API, Pharma or Medical Devices).

Additional Preferences:

• Full understanding of ISA Standards S88/S95Expertise in Lilly’s preferred platforms, including Rockwell Factory Talk, Siemens, Johnson Control, Aveva PI, and Microsoft Operating Systems.
• Knowledge in Historians, and IT platforms such as servers, and workstations.
• Strong technical writing skills
• Ability to work in a safe manner to ensure the safety of self and others.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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