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.
The Scientist – TS/MS – Cleaning Validation will provide direct technical support to the cleaning validation program for fermentation and protein purification manufacturing processes. The candidate will serve as a subject matter expert (SME) for the Cleaning Control Strategy, including cleaning parameters and associated historical and potential failure modes, along with their countermeasures.
This role is responsible for defining and implementing the routine process monitoring plan, ensuring alignment with the Cleaning Control Strategy to maintain process control and capability.
The candidate will be primarily responsible for proactively detecting changes in variability and identifying/implementing appropriate corrective actions. They will lead the cleaning improvement agenda, translate cleaning process requirements, and educate Process Teams and operators. This includes designing, reviewing, and delivering Process School(s) at the start of each campaign, as applicable.
Responsibilities also include technical documentation of the cleaning program in official sources such as Process Flow Diagrams (PFDs), Quality Risk Assessments, manufacturing instructions, SOPs, and technical reports. The candidate will participate in the design and execution of Process, Cleaning, Bioburden Control Strategies, and Validation exercises.
The candidate will ensure the cleaning process remains in a validated state through routine monitoring, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV), and Annual Product Reviews (APR). They will conduct investigations, develop CAPA plans, and present findings to the deviation board. The candidate will own and implement change controls effectively and in a timely manner.
Collaboration with secondary loop personnel, TS/MS laboratory, other functions, and other Lilly manufacturing sites is essential to identify and replicate best practices. The candidate must ensure data integrity and adherence to verification procedures, and provide technical support for cleaning processes related to new product introductions.
Basic Qualifications
Bachelor’s or Master’s degree in scientific disciplines such as Chemistry, Engineering, or Chemical Engineering.
3–5 years of experience in a cleaning validation program within a regulated pharmaceutical manufacturing environment.
Additional relevant industrial experience in Engineering, Development, or Quality in Pharmaceutical or Protein Manufacturing Operations is desirable.
Knowledge of cGMPs.
Strong technical writing and presentation skills.
Proficiency in process data analysis using statistical tools.
Excellent interpersonal skills that foster engagement and teamwork in a cross-functional environment.
Other Requirements
Fully bilingual (English and Spanish).
Team-oriented with strong collaboration skills.
Ability to influence and exercise sound judgment.
Demonstrated leadership capabilities.
Excellent oral and written communication skills.
Ability to manage multiple assignments in a dynamic environment.
Availability to support 24/7 operations.
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.
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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$52,500 - $154,000Full-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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