Principal Scientist – TS/MS Visual Inspection Full-time NEW

Principal Scientist – Visual Inspection

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Responsibilities:

The Principal Scientist – Visual Inspection will assume responsibility across the LKC 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. 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 Lilly Kenosha County site.
• Be responsible with respect to implementation of regulatory guidance (e.g. USP <1790>), technology advancements, and understanding of how changes could impact Eli 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.

Basic Qualifications:

• Minimum of bachelor's degree in science or engineering field
• 3+ years proven experience in visual inspection of pharmaceutical products

Additional Skills/Preferences:

• Preferred 5+ years proven experience directly supporting pharmaceutical manufacturing or quality, with experience in visual inspection of pharmaceutical products.
• Ability to influence and communicate to diverse groups on sophisticated regulatory, business, or technical issues within the site and function.
• Responsible for maintaining a safe work environment.
• Experience in statistics and stackable tolerance analysis, 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.

Additional Information:

• 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.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 – $167,200. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees.