Principal Scientist Visual Inspection Steward

Principal Scientist Visual Inspection - Technical Services/Manufacturing Science (m/w/d)

The TS/MS Visual Inspection (VI) Principal Scientist will assume responsibility across the manufacturing site in terms of ownership and harmonization of local control strategy that are implemented and executed at the site with regard to the Visual Inspection program. As a subject matter expert, he/she will be a key member of a cross‑functional team, providing technical guidance for inspection operations and projects while teaching, mentoring and coaching personnel in all aspects relating to visual inspection processes. They will also oversee the training and qualification program, participate in troubleshooting and continuous improvement, investigations, regulatory inspections, and site inspection readiness programs. Additionally, the role involves regular interaction with peers and Global TS/MS to share learning and align strategies with technical, quality, and regulatory guidance, while supporting business expectations.

Key Responsibilities

• Serve as technical subject matter expert and program owner for all topics related to visual inspection supporting the site.
• Responsible for implementation of regulatory guidance (e.g., USP), technological advancements, and understanding of how changes could impact Lilly.
• Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to support production operations.
• Provide technical support for non‑routine investigations (e.g., deviations, complaints).
• Author, review, or approve technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, qualifications, procedures, defect classifications, technical studies, etc.
• Develop, monitor, and appropriately react to established statistically based metrics to assess process variability and capability.
• Own the development and implementation of process improvements to improve process control, yield, and/or efficiency.
• Interact with regulators, customers, and other outside stakeholders on business issues or in support of internal and external agency audits.

Basic Qualifications

• Minimum of bachelor’s degree in science or engineering field.
• Minimum 2+ years proven experience in visual inspection of pharmaceutical products.
• Preferred 5+ years proven experience directly supporting pharmaceutical manufacturing or quality, with experience in visual inspection of pharmaceutical products.

Skills & Preferences

• Technical writing and communication skills are used daily; ability to effectively communicate and transfer knowledge to all levels of the organization is essential.
• Ability to train/coach others and cross‑functional influence are critical in this role.
• Ability to communicate to diverse groups on sophisticated regulatory, business, or technical issues within the site and function.
• Experience in basic statistics and ANSI Standards.
• Build relationships with internal and external customers and partners.
• Proficiency in delivering highly sophisticated tasks and/or tasks that are highly cross‑functional.
• Strong analytical and quantitative problem‑solving skills.
• Demonstrated project management skills and ability to coordinate complex projects.
• Strategic thinking and ability to balance short‑term needs with long‑term business evolution.

Additional Information

• Role is Monday through Friday. Must be flexible in providing support to accommodate production schedules, shutdowns, etc. Occasional extended hours and/or off‑hour work may be required.

Lilly 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.