Principal Scientist Visual Inspection Steward Full-time

Principal Scientist Visual Inspection – Technical Services/Manufacturing Science

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

In this role you will be part of the TSMS (Technical Services / Manufacturing Science) team (also known as MSAT or MS&T). The TSMS team is the technical owner of the process — from tech transfer and validation through commercial lifecycle management. Our decisions on control strategy, lifecycle, and process robustness shape how this greenfield parenteral site runs for the next decades, with direct visibility to site leadership and Lilly's global technical network.

Responsibilities:

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 regarding the Visual Inspection program. As a Subject Matter Expert (SME), he is a key member in a cross-functional team who provides technical guidance for inspection operations and projects and is responsible for teaching, mentoring and coaching personnel in all aspects relating to visual inspection processes. The VI Principal Scientist is responsible for the training and qualification program associated with visual inspection and classification of defects and ensuring overall scientific understanding of the program. She/He also participates in troubleshooting and driving continuous improvement as it relates to the visual inspection program. The visual inspection Principal Scientist can also participate in investigations, regulatory inspections and collaborate in site inspection readiness programs. The role will regularly interact with peers within the network and in Global TS/MS to share learning and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.

Key Objectives/Deliverables:

• Serve as technical subject matter expert and program owner for all topics related to visual inspection supporting the site.
• Is responsible with respect to implementation of regulatory guidance (e.g. USP <1790>), technological advancements, and understanding of how changes could impact Eli 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, personnel qualification strategies, control strategies, 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, or 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 and the 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 other inputs (production schedules, shutdowns, etc.). Occasional extended hours and /or off-hour work may be required.

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 for further assistance. 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.