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  1. Home
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  5. Validation Engineer/Scientist
Eli Lilly and Company logo

Validation Engineer/Scientist

Not Disclosed•Full-TimeOn-site

location_onCooper Road, Village Green Heights, Pleasant Prairie, Kenosha County, Wisconsin, 53158, United States

Apply Now

About Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees 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 put people first and are dedicated to finding individuals who share our determination to improve lives globally.

About the Role

The Validation Engineer/Scientist - Technical Services / Manufacturing Science (TS/MS) is a pivotal technical position designed to develop and support the validation of production equipment and systems at the Lilly Kenosha County site. This role provides essential technical leadership regarding temperature mapping, cleaning, and sterilization validation strategies to ensure the compliant start-up and manufacturing of parenteral drug products.

In this capacity, you will serve as a mentor within the TSMS team and engage in both upstream and external site activities related to validation. You will act as a key interface for cleaning and sterilization programs, collaborating with partners across the Parenteral Network and specific product supply chains. The role requires a deep understanding of the scientific principles governing parenteral manufacturing, including the interaction of chemistry, equipment, aseptic processes, and container closure systems. You will lead or support root cause investigations, analyze manufacturing data to identify trends and opportunities for continuous improvement, and ensure a safe working environment by actively participating in safety-related activities.

Hiring Process

Candidates interested in this position should submit their application through the Lilly careers portal. For individuals requiring accommodation to submit a resume or participate in the application process, please complete the accommodation request form available on the Lilly careers website.

Our Culture and Commitment to Diversity

Lilly is proud to be an Equal Opportunity 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. We are dedicated to helping individuals with disabilities actively engage in the workforce.

Our Employee Resource Groups (ERGs) offer strong support networks for their members and are open to all employees. Current groups include the 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); and enAble (for people with disabilities).

Compensation and Benefits

Actual compensation for this position will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage range is $66,000 - $171,600. Full-time equivalent employees are eligible for a company bonus, depending in part on company and individual performance. Additionally, eligible employees participate in a comprehensive benefit program, including a company-sponsored 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug coverage, flexible spending accounts, life insurance, and well-being benefits such as the employee assistance program and fitness benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Work location

Work model: On-site

location_on

Cooper Road, Village Green Heights, Pleasant Prairie, Kenosha County, Wisconsin, 53158, United States

Pleasant Prairie, Wisconsin

Key Responsibilities

  • check_circleAuthor and support the execution of validation protocols and summary reports
  • check_circleLead root cause investigations related to cleaning, sterilization, and manufacturing processes
  • check_circleAnalyze manufacturing data using statistical principles to identify trends and improvement opportunities
  • check_circleCoordinate with cross-functional teams to implement projects for productivity and quality improvements
  • check_circleParticipate in internal and external audits and regulatory inspections for cleaning and sterilization programs
  • check_circlePrepare and review technical documents including change controls, deviation investigations, and regulatory submissions
  • check_circleServe as a mentor and provide technical leadership within the TS/MS team
  • check_circleCollaborate with partners across the Parenteral Network to influence product supply chain activities

Requirements

  • verifiedBachelor's degree in microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
  • verified2+ years' experience supporting cGMP manufacturing
  • verifiedExperience executing equipment qualification, cleaning validation, and sterilization validation
  • verifiedExperience with data trending and analysis

Nice to Have

Experience executing equipment qualification, cleaning validation, and sterilization validation; experience with data trending and analysis; ability to analyze complex data and solve problems; strong interpersonal skills to work cross-functionally within a team; strong self-management and organizational skills.

Benefits & Perks

check_circleEligibility to participate in a company-sponsored 401(k)check_circlePension plancheck_circleVacation benefitscheck_circleMedical, dental, vision, and prescription drug benefitsFlexible benefits including healthcare and dependent day care flexible spending accounts
Eli Lilly and Company cover image
Eli Lilly and Company logo
Company

Eli Lilly and Company

Industry

Pharmaceutical Manufacturing

Headquarters

Indianapolis, Indiana

Open Roles

1

Lilly is a pharmaceutical manufacturing company dedicated to transforming scientific innovation into solutions that improve global health. Founded in 1876, the company focuses on advancing biotechnology, chemistry, and genetic medicine to address critical health challenges. Based in Indianapolis, Indiana, Lilly’s work spans research, development, and delivery of medicines designed to enhance patient outcomes. The company operates under the guiding principle established by its founder, Colonel Eli Lilly: to continuously refine and improve scientific discoveries for the benefit of people worldwide. With a long-term commitment to science-driven progress, Lilly collaborates across disciplines to accelerate breakthroughs in areas of significant unmet medical need. Its efforts reflect a mission rooted in innovation, quality, and a dedication to making a measurable impact on global healthcare. The organization supports patients, healthcare providers, and communities through its portfolio of therapies and ongoing scientific exploration.

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Skills, education and keywords

Skills: CGMP, Equipment Qualification, Cleaning Validation, Sterilization Validation, Temperature Mapping, Filter Validation, Aseptic Processes, Data Trending, Data Analysis, Root Cause Investigations.

Education: Bachelor's degree in microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline required.

Frequently asked questions about Validation Engineer/Scientist at Eli Lilly and Company

What does a Validation Engineer/Scientist at Eli Lilly and Company do?expand_more
A Validation Engineer/Scientist at Eli Lilly and Company is responsible for the following: Author and support the execution of validation protocols and summary reports; Lead root cause investigations related to cleaning, sterilization, and manufacturing processes; Analyze manufacturing data using statistical principles to identify trends and improvement opportunities; and Coordinate with cross-functional teams to implement projects for productivity and quality improvements.
What are the requirements for this Validation Engineer/Scientist role?expand_more
Eli Lilly and Company is looking for candidates who meet the following requirements: Bachelor's degree in microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline; 2+ years' experience supporting cGMP manufacturing; Experience executing equipment qualification, cleaning validation, and sterilization validation; and Experience with data trending and analysis.
Where is the Validation Engineer/Scientist role at Eli Lilly and Company located?expand_more
Validation Engineer/Scientist at Eli Lilly and Company is based in Cooper Road, Village Green Heights, Pleasant Prairie, Kenosha County, Wisconsin, 53158, United States. This is a on-site role.
Is this Validation Engineer/Scientist job remote, hybrid, or on-site?expand_more
Eli Lilly and Company has listed this Validation Engineer/Scientist role as on-site.
How much experience is required for this Validation Engineer/Scientist role?expand_more
Validation Engineer/Scientist at Eli Lilly and Company typically requires 2+ years of relevant experience at the mid level level.
What skills do you need for the Validation Engineer/Scientist role at Eli Lilly and Company?expand_more
Key skills for Validation Engineer/Scientist at Eli Lilly and Company include CGMP; Equipment Qualification; Cleaning Validation; Sterilization Validation; Temperature Mapping; Filter Validation; Aseptic Processes; and Data Trending.
What education is required for Validation Engineer/Scientist at Eli Lilly and Company?expand_more
Educational requirements for this role: Bachelor's degree in microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline required.
What category does the Validation Engineer/Scientist role belong to?expand_more
Validation Engineer/Scientist at Eli Lilly and Company is part of the scientific & qa job category on Recrutus.

About Eli Lilly and Company

Lilly is a pharmaceutical manufacturing company dedicated to transforming scientific innovation into solutions that improve global health. Founded in 1876, the company focuses on advancing biotechnology, chemistry, and genetic medicine to address critical health challenges. Based in Indianapolis, Indiana, Lilly’s work spans research, development, and delivery of medicines designed to enhance patient outcomes. The company operates under the guiding principle established by its founder, Colonel Eli Lilly: to continuously refine and improve scientific discoveries for the benefit of people worldwide. With a long-term commitment to science-driven progress, Lilly collaborates across disciplines to accelerate breakthroughs in areas of significant unmet medical need. Its efforts reflect a mission rooted in innovation, quality, and a dedication to making a measurable impact on global healthcare. The organization supports patients, healthcare providers, and communities through its portfolio of therapies and ongoing scientific exploration.

Browse more roles: All Eli Lilly and Company jobs, scientific & qa jobs on Recrutus.

Recrutus

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Search roles by city, category, skill, or job type — explore verified US employers, salary benchmarks, and remote-friendly teams hiring nationwide.

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About usFAQContactPrivacy policyUS privacy notice

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check_circle
Develop and execute cleaning and sterilization validation strategies for production equipment
  • check_circleProvide technical support for temperature mapping, cleaning, and sterilization program start-ups
  • check_circleEnsure a safe working environment through compliance with safety rules and active participation in safety activities
  • check_circle
    check_circleLife insurance and death benefits
    check_circleTime off and leave of absence benefits
    check_circleWell-being benefits including employee assistance program and fitness benefits
    check_circleEligibility for a company bonus based on company and individual performance
    View company profilearrow_forwardlanguageWebsitelinkLinkedIn
    Quick Overview

    Experience

    2+ yrs (Mid Level)

    Education

    Bachelor's degree in microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline required

    Job Type

    Full-Time

    Skills Required

    CGMPEquipment QualificationCleaning ValidationSterilization ValidationTemperature MappingFilter ValidationAseptic ProcessesData TrendingData AnalysisRoot Cause Investigations
    Accessibility