Principal Scientist – TS/MS Visual Inspection

Role Summary

Principal Scientist - Visual Inspection at the Lilly Kenosha County site, responsible for ownership and harmonization of local control strategy for the Visual Inspection program across the LKC manufacturing site. Collaborates with peers within the network and Global TS/MS to share learnings and ensure strategies align with technical, quality, and regulatory guidance while supporting business expectations.

Responsibilities

• Serve as technical subject matter expert and program owner for all topics related to visual inspection supporting the Lilly Kenosha County site.
• Responsible for implementation of regulatory guidance (e.g., USP), technology advancements, and understanding of how changes could impact Lilly.
• Provide technical consultation regarding defect classification and visual inspection technique.
• Author, review, or approve technical documents, including personnel qualification strategies, control strategies, investigations, change controls, qualifications, procedures, defect classifications, technical studies, etc.
• Interact with regulators, customers, or other outside partners on business issues or in support of internal and external agency audits.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
• Own the development and implementation of process improvements to improve process control, yield, and/or efficiency.
• Technical writing and communication skills are used daily and the ability to optimally communicate and transfer knowledge to all levels of the organization is crucial.
• Provide technical support for non-routine investigations (e.g., deviations, complaints).
• Lead/participate in KNAPP studies, and/or operator training/qualification studies.
• Although not a supervisory role, technical leadership, and the ability to train/mentor others and cross functionally influence are important in this role.

Qualifications

• Required: Minimum of bachelor's degree in science or engineering field.
• Required: 3+ 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.
• Preferred: Ability to influence and communicate to diverse groups on sophisticated regulatory, business, or technical issues within the site and function.
• Preferred: Responsible for maintaining a safe work environment.
• Preferred: Experience in statistics and stackable tolerance analysis, ANSI Standards.
• Preferred: Build relationships with internal and external customers and partners.
• Preferred: Proficiency in delivering highly sophisticated tasks and/or tasks that are highly cross-functional.
• Preferred: Strong analytical and quantitative problem-solving skills.

Skills

• Technical writing and communication
• Analytical and quantitative problem-solving
• Cross-functional collaboration and influence
• Regulatory and quality systems knowledge (e.g., USP)
• Visual inspection techniques and process improvement

Additional Requirements

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