Eli Lilly and Company
TSMS Sterility Assurance Scientist
Eli Lilly and Company, Pleasant Prairie, Wisconsin, United States, 53158
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TSMS Sterility Assurance Scientist
role at
Eli Lilly and Company .
At Lilly we unite caring with discovery to make life better for people around the world. Our employees around the world work to discover and bring life‑changing medicines to those who need them.
Responsibilities The Sterility Assurance Scientist assists in development and implementation of the site’s sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy.
Key Objectives / Deliverables
Oversight of sterility assurance programs at manufacturing floor level
Technical support for activities related to sterility assurance programs
Airflow pattern testing
Environmental monitoring performance qualifications
Aseptic process simulations
Cleaning, sanitization, and disinfection
Gowning within GMP classified areas
Aseptic processing techniques
Contamination control
Assist in development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established
(Senior) Lead or assist in development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established
(Senior) Lead/assist with support & technical expertise for developing the site’s contamination control strategy and cleaning & sanitization program/strategy, and disinfectant efficacy strategies
(Senior) Lead/assist with support & technical expertise for the facility’s cleanroom gowning and aseptic technique strategy/program
(Principal) Knowledge in pharmaceutical microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification
(Principal) Lead / provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program
(EM) Authoring EM performance qualifications (EM PQ) and overseeing the execution
(EM) Evaluating EM data and authoring EM trend reports
(EM) Assist with identifying facility environmental isolates and how to create and maintain environmental isolate cultures
(APS) Authoring APS protocols and overseeing the execution
(APS) Evaluating the APS data, including personnel qualifications, and authoring APS reports
(APS) Assist with tracking and tending APS to ensure all regulatory requirements and Global Quality Standards are met for each manufacturing line/process
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements
Lead or provide technical support for root cause investigations associated with sterility assurance programs
Participate and/or provide technical sterility assurance support during internal and external audits
Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs
Work within cross‑functional teams to implement TS/MS objective and deliver on business and quality objectives
Basic Qualifications
Bachelor’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
Additional Skills / Preferences
Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated with cGMP pharmaceutical manufacturing
2+ years in pharmaceutical manufacturing preferred (Microbiology, TSMS, Sterility Assurance, or related dept)
Possess strong interpersonal skills to work cross‑functionally within a team
Possess strong self‑management and organizational skills
Possess strong oral and written communication skills for communicating to colleagues, management, and other departments
Experience with data analysis and trending
Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing, warehouse, or laboratory areas
Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities
Additional Information
Role is Monday through Friday based and will be phased from a project support role to a routine support role as the development facility and processes progress. 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
Tasks may require repetitive motion and standing or walking for long periods of time
Travel may be required during the project phase for training and implementation of sterility assurance programs
Equal Employment Opportunity Lilly is a proud 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 to 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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.
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 - $171,600.
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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TSMS Sterility Assurance Scientist
role at
Eli Lilly and Company .
At Lilly we unite caring with discovery to make life better for people around the world. Our employees around the world work to discover and bring life‑changing medicines to those who need them.
Responsibilities The Sterility Assurance Scientist assists in development and implementation of the site’s sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy.
Key Objectives / Deliverables
Oversight of sterility assurance programs at manufacturing floor level
Technical support for activities related to sterility assurance programs
Airflow pattern testing
Environmental monitoring performance qualifications
Aseptic process simulations
Cleaning, sanitization, and disinfection
Gowning within GMP classified areas
Aseptic processing techniques
Contamination control
Assist in development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established
(Senior) Lead or assist in development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established
(Senior) Lead/assist with support & technical expertise for developing the site’s contamination control strategy and cleaning & sanitization program/strategy, and disinfectant efficacy strategies
(Senior) Lead/assist with support & technical expertise for the facility’s cleanroom gowning and aseptic technique strategy/program
(Principal) Knowledge in pharmaceutical microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification
(Principal) Lead / provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program
(EM) Authoring EM performance qualifications (EM PQ) and overseeing the execution
(EM) Evaluating EM data and authoring EM trend reports
(EM) Assist with identifying facility environmental isolates and how to create and maintain environmental isolate cultures
(APS) Authoring APS protocols and overseeing the execution
(APS) Evaluating the APS data, including personnel qualifications, and authoring APS reports
(APS) Assist with tracking and tending APS to ensure all regulatory requirements and Global Quality Standards are met for each manufacturing line/process
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements
Lead or provide technical support for root cause investigations associated with sterility assurance programs
Participate and/or provide technical sterility assurance support during internal and external audits
Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs
Work within cross‑functional teams to implement TS/MS objective and deliver on business and quality objectives
Basic Qualifications
Bachelor’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
Additional Skills / Preferences
Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated with cGMP pharmaceutical manufacturing
2+ years in pharmaceutical manufacturing preferred (Microbiology, TSMS, Sterility Assurance, or related dept)
Possess strong interpersonal skills to work cross‑functionally within a team
Possess strong self‑management and organizational skills
Possess strong oral and written communication skills for communicating to colleagues, management, and other departments
Experience with data analysis and trending
Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing, warehouse, or laboratory areas
Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities
Additional Information
Role is Monday through Friday based and will be phased from a project support role to a routine support role as the development facility and processes progress. 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
Tasks may require repetitive motion and standing or walking for long periods of time
Travel may be required during the project phase for training and implementation of sterility assurance programs
Equal Employment Opportunity Lilly is a proud 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 to 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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.
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 - $171,600.
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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