Job Information
Lilly Scientist-TS/MS Data Integrity 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 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.
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