Process Control and Automation Engineer-CSV

2 weeks ago

Lebanon, United States Eli Lilly Full time

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:

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 35,000 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 (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.

Responsibilities:

  • Work safely and continually look for improvements to both people and equipment safety.

  • Provide site engineering input to Commissioning and Qualification and Data Integrity programs.

  • Execute and develop best practices and standards to support manufacturing and major capital project delivery.

  • Review or develop Automation system SDLC (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.

  • Innovation – Evaluate new technologies for potential integration to ensure data integrity requirements are met.

  • Work globally with other Lilly manufacturing sites to share best practices


Basic Requirements:

  • Ability to work in a safe manner to ensure the safety of self and others.

  • BS in Engineering, Computer Science, or related Science/Information Technology Field

  • 3+ years’ experience in process automation engineering or information technology, preferably supporting an API manufacturing site.

  • 3+ Years of experience in one or more process automation platforms demonstrated with work experience and/or training (DeltaV/Rockwell/ Johnsons Controls).

  • 2+ Years Experience working in a cGMP regulated industry (API, Pharma or Medical Devices).

  • 3+ Years Experience leading and/or supporting Commissioning and Qualification strategies and tasks on Automated/Computerized systems.


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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

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