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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.

Position Title:

Sr. Principal Engineer – TSMS Visual Inspection

Job Level:

R4

Job Family Group/Family

TSMS

Supervisor:

Associate Director – TSMS

Location:

Kenosha Site

Position Description:

The Visual Inspection Engineer – Technical Services / Manufacturing Science (TS/MS) role provides technical guidance for visual inspection operations and projects involving existing and new inspection processes.

The role is responsible for teaching, mentoring, and coaching personnel in all aspects relating to visual inspection processes within the Lilly Kenosha County site. The scope of the role includes visual inspection operations for commercially manufactured products at the Kenosha site.

The Visual Inspection Engineer is responsible for the training and qualification program associated with visual inspection, classification of defects, and ensuring overall scientific understanding of the program. This role will also participate in troubleshooting and driving continuous improvement as it relates to the visual inspection program.

The role will regularly interact with peers within the parenteral network and in Global TS/MS to share learnings and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.

Key Objectives/Deliverables:

+ Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.

+ Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to support production operations.

+ Perform root cause analysis and apply scientific principles and understanding related to defect creation, prevention, and detection.

+ Author, review, approve and provide technical support for the preparation of technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, procedures, processing records, validation protocols and summary reports, defect classifications, technical studies, regulatory submissions, etc.

+ Provide technical support for non-routine investigations (e.g., deviations, complaints), including consultation on quality.

+ Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.

+ Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.

+ Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.

+ Serve as technical interface external to the Kenosha site.

+ Provide audit support, as needed.

+ Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.

+ Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.

+ Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Requirements (Education, Experience, Training):

+ Bachelors Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or other related scientific discipline

+ Minimum 10 years of visual inspection of parenteral drug products

+ Experience in TS/MS, MSAT, Quality, Engineering, or Operations

+ Experience with data trending and analysis

+ Previous experience with deviation and change management systems

Preferred attributes but not required:

+ Ability to analyze complex data and solve problems

+ Demonstrated successful leadership of cross-functional teams

+ Strong interpersonal and teamwork skills

+ Strong self-management and organizational skills

+ Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization

Other Information:

+ Role is Monday through Friday based. 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.

+ Position will be based out of Kenosha site with ability to travel to Indianapolis and other global Lilly sites as required

This job specification 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 specification.  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 ( 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 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

$117,000 - $171,600

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, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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