Scientist-TS/MS Data Integrity

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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