Validation Engineer​/Scientist

Position Overview

Development and support of validation for production equipment and systems, providing technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objective s include start‑up and compliant manufacturing of Lilly Kenosha County products and implementation of validation strategies, including sterilization, cleaning, filter and other related activities. Role includes mentorship within the TS/MS team and engagement in upstream and external validation activities.

• Understand scientific principles for manufacturing parenteral drug products, including chemistry, equipment, aseptic processes, and container closure systems.
• Provide technical support for all start‑up activities related to temperature mapping, cleaning and sterilization programs.
• Develop or assist in designing and executing cleaning and sterilization strategies for production equipment and systems (e.g., tanks, component/parts washers, autoclaves, filling isolators).
• Support periodic requalification of production equipment and systems.
• Author and support execution of validation protocols and reports.
• Provide technical guidance to the Process Team for cleaning and sterilization processes.
• Lead or support root‑cause investigations for cleaning, sterilization and related activities.
• Analyze manufacturing data with statistical principles to identify trends, disruptions and continuous improvement opportunities.
• Coordinate with cross‑functional process teams to implement productivity, quality and continuous improvement projects.
• Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections.
• Prepare, review, approve and support preparation of technical documents such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs and related documents.
• Support and/or lead TS/MS technical projects to ensure successful start‑up, process control, yield, product quality and/or productivity improvements.
• Implement process changes and improvements through the technical agenda.
• Serve as cleaning and/or sterilization interface external to the Lilly Kenosha County site.
• Work within or lead cross‑functional teams to implement TS/MS objectives and deliver on business plan and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and specific product supply chains.
• Ensure a safe working environment through compliance with safety rules and improve the safety culture by actively participating in safety‑related activities.

• Bachelor’s degree in microbiology, biology, biochemistry, biochemical engineering, chemical engineering or a related scientific discipline.
• At least 2 years of experience supporting cGMP manufacturing (within validation, engineering, technical services, operations, quality assurance, etc.).

• 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, teamwork and cross‑functional collaboration skills.
• Good self‑management and organizational skills.

• Available off‑shift to respond to operational issues.
• Ability to travel (~10%).

Actual compensation will depend on education, experience, skills and geographic location. The anticipated wage for this position is $66,000 - $171,600. Full‑time equivalent employees are also eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefit program including 401(k) participation, pension, vacation and leave benefits, medical, dental, vision, prescription drug coverage, flexible benefits such as healthcare or dependent day‑care flexible spending accounts, life and death benefits, employee assistance program, fitness benefits, and employee clubs and activities.

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. Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form at