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Scientist-TS/MS Data Integrity

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Feb 23, 2024

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Discipline
Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

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.

Responsibilities

The Scientist-TS/MS Data Integrity in IAPI (Indianapolis Active Pharmaceutical Ingredient) will be a core PAT (Process Analytical Technology) team member supporting on-line, at-line, and in-line analytical instrumentation in manufacturing.  The individual in this role will be a key leader in PAT efforts related to Data Integrity Systems Integration and Inspection Readiness.

Key Objectives/Deliverables

  • Work safely and continually look for improvements to both people and equipment safety
  • Work with automation/IT/e-Manufacturing to ensure deployment of MES-compatible PAT equipment with a focus on computer systems, data integrity, and systems integration
  • Comfortable communicating technical information and best practices with teammates and serve as a leader in the community of practice for our site’s Data Integrity journey
  • Be a self-starter with a focus on delivering on data integrity initiatives, combined with a strong understanding of business objectives, manufacturing and quality processes and technologies.  Stay current on emerging IT/OT technologies
  • Be proficient in OSI PI data historian, data analytics/visualization, and seek to understand data flow.  Knowledge in IT platforms such as servers and workstations, MES integration, and enterprise level applications (e.g. Emerson DeltaV)
  • Design and execute CSV initiatives for PAT, assist with TS/MS infrastructure requests, and eLN templates/scripting
  • Lead data integrity risk assessments and evaluate current procedures, system functionality, including but not limited to physical and logical security, Electronic Records/Electronic Signatures (ER/ES), audit trails, data mapping, records/data backup, archive and retention, and computer system validation
  • Support other core PAT activities (e.g. new equipment installation, system upgrades, periodic review, change management, observation/deviation management, and external agency/internal inspections).

Basic Qualifications

  • Bachelor's degree in relevant scientific discipline such as Engineering, Biology, Chemistry, Analytical Chemistry, Biochemistry, Microbiology, Pharmacy, etc.
  • 4+ years of relevant industry experience such as Pharmaceutical Manufacturing, Analytical Equipment, Engineering, Research and Development, Quality Control Laboratory, or Quality Assurance
  • Experience in one or more Lilly-preferred platforms (e.g. including Emerson DeltaV, Emerson Syncade, Microsoft Operating Systems, Tableau, OSI PI and secure servers) demonstrated with work experience and/or training.
  • Ability to work well with people of other cultures and international Lilly sites

Additional Skills/Preferences

  • Experience supporting pharmaceutical manufacturing
  • Analytical Equipment experience
  • Experience interacting with external agencies/inspectors and internal auditors
  • Knowledge in FDA 21 CFR Part 11 compliance

Additional Information

  • 8-hour days, after-hour support may be needed to support urgent business
  • Occasional travel may be required for training, conferences, capital projects, etc.

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

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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