Scientist-TS/MS Data Integrity

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.

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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