BioSpace
TSMS Sterility Assurance Scientist
BioSpace, Pleasant Prairie, Wisconsin, United States, 53158
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TSMS Sterility Assurance Scientist
role at
BioSpace
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.
Responsibilities
The Sterility Assurance Scientist is a technical role that 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.
Develop and implement a technical agenda and provide technical leadership for the Parenteral Process Team.
Serve as a mentor within the TSMS team and engage in upstream and external site activities related to sterility assurance.
Key Objectives / Deliverables
(Associate / Senior) Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.
Lead or provide technical oversight for activities related to sterility assurance programs, including but not limited to:
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 developing and implementing processes and facility monitoring to ensure effective contamination control strategies are established.
Lead or assist in developing and implementing contamination control strategies, cleaning and sanitization programs, disinfectant efficacy strategies, and cleanroom gowning and aseptic technique strategies.
For a Principal, possess knowledge in pharmaceutical microbiology, including microbiological media, enumeration techniques, and microorganism isolation and identification.
Lead or provide technical oversight for the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program:
(EM) Author EM performance qualifications and oversee execution.
(EM) Evaluate EM data and author EM trend reports.
(EM) Assist with identifying environmental isolates and creating maintainable cultures.
(APS) Author APS protocols and oversee execution.
(APS) Evaluate APS data, including personnel qualifications, and author APS reports.
(APS) Assist with tracking and tending APS to ensure regulatory and global quality standards are met for each manufacturing line or 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 improvement.
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 objectives and deliver on business and quality objectives.
Basic Qualifications
Bachelor’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or another 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 in cGMP pharmaceutical manufacturing.
Two or more years in pharmaceutical manufacturing preferred (Microbiology, TSMS, Sterility Assurance, or related department).
Strong interpersonal skills to work cross‑functionally within a team.
Strong self‑management and organizational skills.
Strong oral and written communication skills for communicating with colleagues, management, and other departments.
Experience with data analysis and trending.
Ability to wear appropriate PPE and other safety equipment 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 transition from a project‑support role to a routine support role as development facility and processes progress. Must be flexible to accommodate production schedules, shutdowns, etc.; occasional extended or off‑hour work may be required.
Tasks may require repetitive motion, standing, or walking for long periods.
Travel may be required during the project phase for training and implementation of sterility assurance programs.
Equal Employment Opportunity Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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.
Compensation & Benefits Salary range: $66,000 – $171,600. Full‑time employees are also eligible for the company bonus program and a comprehensive benefit plan, including 401(k) sponsorship, pension, vacation, health, dental, vision, prescription drug benefits, flexible benefits, life insurance, and wellness programs.
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TSMS Sterility Assurance Scientist
role at
BioSpace
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.
Responsibilities
The Sterility Assurance Scientist is a technical role that 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.
Develop and implement a technical agenda and provide technical leadership for the Parenteral Process Team.
Serve as a mentor within the TSMS team and engage in upstream and external site activities related to sterility assurance.
Key Objectives / Deliverables
(Associate / Senior) Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.
Lead or provide technical oversight for activities related to sterility assurance programs, including but not limited to:
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 developing and implementing processes and facility monitoring to ensure effective contamination control strategies are established.
Lead or assist in developing and implementing contamination control strategies, cleaning and sanitization programs, disinfectant efficacy strategies, and cleanroom gowning and aseptic technique strategies.
For a Principal, possess knowledge in pharmaceutical microbiology, including microbiological media, enumeration techniques, and microorganism isolation and identification.
Lead or provide technical oversight for the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program:
(EM) Author EM performance qualifications and oversee execution.
(EM) Evaluate EM data and author EM trend reports.
(EM) Assist with identifying environmental isolates and creating maintainable cultures.
(APS) Author APS protocols and oversee execution.
(APS) Evaluate APS data, including personnel qualifications, and author APS reports.
(APS) Assist with tracking and tending APS to ensure regulatory and global quality standards are met for each manufacturing line or 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 improvement.
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 objectives and deliver on business and quality objectives.
Basic Qualifications
Bachelor’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or another 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 in cGMP pharmaceutical manufacturing.
Two or more years in pharmaceutical manufacturing preferred (Microbiology, TSMS, Sterility Assurance, or related department).
Strong interpersonal skills to work cross‑functionally within a team.
Strong self‑management and organizational skills.
Strong oral and written communication skills for communicating with colleagues, management, and other departments.
Experience with data analysis and trending.
Ability to wear appropriate PPE and other safety equipment 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 transition from a project‑support role to a routine support role as development facility and processes progress. Must be flexible to accommodate production schedules, shutdowns, etc.; occasional extended or off‑hour work may be required.
Tasks may require repetitive motion, standing, or walking for long periods.
Travel may be required during the project phase for training and implementation of sterility assurance programs.
Equal Employment Opportunity Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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.
Compensation & Benefits Salary range: $66,000 – $171,600. Full‑time employees are also eligible for the company bonus program and a comprehensive benefit plan, including 401(k) sponsorship, pension, vacation, health, dental, vision, prescription drug benefits, flexible benefits, life insurance, and wellness programs.
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