Sterility Assurance Scientist , Technical Services / Manufacturing Sciences

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 OverviewThe Sterility Assurance Scientist helps ensure our manufacturing processes meet the highest standards of cleanliness and contamination control. This role supports and improves site programs related to sterility assurance and provides technical guidance in areas such as:Environmental monitoringContamination controlAseptic (sterile) processing techniquesCleanroom gowning practicesCleaning and sanitization (including disinfectant effectiveness)At the Principal level, this role also leads technical strategy, provides guidance to the Parenteral Process Team, mentors team members, and supports broader company initiatives related to sterility assurance.Key ResponsibilitiesProvide technical support and guidance for sterility assurance programs on the manufacturing floorSupport or lead activities such as:Airflow testingEnvironmental monitoring (EM)Aseptic process simulations (APS)Cleaning, sanitization, and disinfectionCleanroom gowning and aseptic practicesHelp develop and improve contamination control strategies and facility monitoring programsAnalyze data to identify trends, issues, and improvement opportunitiesSupport or lead investigations into contamination or sterility-related issuesParticipate in internal and external auditsWrite, review, and approve technical documents and change controlsWork cross-functionally to meet quality and business objectivesSenior-level additional responsibilities:Lead development of contamination control strategies and cleaning/sanitization programsSupport gowning and aseptic technique programsPrincipal-level additional responsibilities:Provide technical leadership for Environmental Monitoring (EM) and/or Aseptic Process Simulation (APS) programsReview data, write reports, and ensure compliance with quality standardsMentor team members and contribute to site-wide and external sterility initiativesApply risk management to evaluate contamination risks (microbial, endotoxin, particulate)Basic QualificationsBachelor’s degree in microbiology, Biology, Biochemistry, Engineering, or a related field2+ years of experience in cGMP manufacturing (e.g., quality, validation, operations, or technical services) preferredUnderstanding of sterile manufacturing and contamination control principlesExperience in pharmaceutical manufacturing preferredQualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1Preferred SkillsAble to work in cleanroom environments and wear required PPEStrong teamwork and communication skillsGood organization and time managementExperience analyzing and trending dataAdditional InformationMay need to support off-shift issues occasionallyPrimary location: Kenosha County, WIUp to 10% travelThis job description 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 description. For GMP purposes, the job description should be updated for significant changes.  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$66,000 - $171,600Full-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 abse