Principal Scientist Visual Inspection Steward Full-time

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

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.”

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:

• 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. 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.

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