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Lilly Scientist – TS/MS - eMfg in Indianapolis, Indiana

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.

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 39,000 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. #WeAreLilly

The Scientist Technical Services/Manufacturing Science (TSMS) of electronic Manufacturing (eMfg) is responsible for delivery of electronic manufacturing batch records at the Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site. The Scientist will be responsible for implementation and is the TSMS liaison between the eMfg Team and the local Technical Services representatives that support production activities. The Scientists is part of the eMfg Core Team which will develop and deploy electronic solutions to convert paper to an electronic solution for batch records, logbooks, and any paper activity for batch production purposes. Additionally, the Scientist will work with TSMS to ensure that all Regulatory requirements as part of the batch production activities are met when converting paper to electronic as implementation occurs.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

  • Utilize information from eMFG Core Team to develop electronic manufacturing user requirements documents.

  • Engage during discovery phase to deconstruct the paper ticket to define production requirements while using a Lean approach.

  • Ensure electronic solutions interface appropriately with other systems including Darwin, SAP, Veeva, Compliance Suite, etc.

  • Ensure electronic solutions provide a robust method for gathering and analyzing process data

  • Identify areas of improvement in the automation code and/or electronic batch record or logbook to improve efficiency.

  • Provide input into the development of an overarching electronic strategy.

  • Provide input for the development of an electronic implementation schedule, and perform activities in accordance with the schedule

  • Ensure systems can be executed in a manner following all HSE (Health and Safety and Environment) and GMP requirements.

  • Support production as technical support / contact during implementation into production

  • Provide input to the development of the training materials for each area to be used for implementation

  • Provide input into the definition of the future organization to support manufacturing (post implementation).

Basic Qualifications:

  • Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.

  • At least five years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement.

Additional Skills/Preferences:

  • Detailed knowledge of API Operations and batch production record archetypes

  • Knowledge of DeltaV

  • Ability to clearly communicate while influencing and leading diverse groups

  • Knowledge and experience with Regulatory requirements

  • Knowledge of data management practices across manufacturing

  • Responsible for maintaining a safe work environment

  • Builds relationships with internal and external customers and partners

  • Enthusiasm for changes, team spirit and flexibility

  • Demonstrated ability to learn & apply technical/scientific knowledge

  • Experiences working with and driving change

  • High-quality skills to include: Teamwork and interpersonal, technical knowledge of processes, leadership, independent decision making, multi-tasking, ability to influence diverse groups, creative thinking

Additional Information:

  • Minimal travel (<10%) may be required

  • Some off-shift work (night/weekend) may be required to support 24/7 operations

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 ( LillyRecruitingCompliance@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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

#WeAreLilly

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