Principal Scientist Visual Inspection Steward

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.

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.

At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People."

Join our Lilly team in Alzey and start as soon as possible as:

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

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

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