India Job Openings
Lilly
Scientist-TS/MS Data Integrity
Indianapolis
FULL TIME
October 16, 2024
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 Delta V)
- Design and execute CSV initiatives for PAT, assist with TS/MS infrastructure requests, and e LN 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 Delta V, 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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
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