BioSpace
Scientist - TS/MS - Sterility Assurance Technology
BioSpace, Indianapolis, Indiana, us, 46262
Scientist - TS/MS - Sterility Assurance Technology
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.
Organization 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 39,000 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 Brand Description The Scientist positions in the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS / MS – SAT) group are positions that provide support for control of the site’s manufacturing facilities. The group develops and implements sterility assurance related initiatives and provides technical leadership with regard to sterility assurance strategies.
Responsibilities
Ensure site’s Environmental Monitoring, Aseptic Process Simulations, Facility Cleaning, Facility Sanitization, Sterility Assurance Risk Management, and other sterility assurance programs are followed at the manufacturing Flow level.
Provide technical guidance to the Flow and Process Teams for sterility assurance programs.
Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
Lead or provide technical support for root cause investigations for sterility assurance programs.
Use of sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
Execute and assist in the development of process and facility monitoring strategies that focus on areas of highest microbial risk.
Lead site aseptic self-inspection program including communication of observations and recommendations for continuous improvement to manufacturing and support personnel.
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
Create, execute, review and/or approve technical documents related to sterility assurance programs including risk assessments, justification documents, protocols, and summary reports.
Create, execute and/or review change controls related to sterility assurance programs.
Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends.
Participate in continuous improvement projects to improve quality performance at the site.
Participate or provide guidance for sterility assurance programs during regulatory audits.
Provide content and/or data integrity reviews for regulatory submissions.
Lead training courses related to sterility assurance programs.
Basic Qualifications
Bachelor’s degree in Microbiology, Biology, or other STEM related discipline in conjunction with relevant experience.
Additional Skills/Preferences
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Understanding of GMPs and applicable internal standards
Parenteral Manufacturing experience
Communication (oral and written) skills; technical writing skills
Teamwork / interpersonal skills
Experience with data trending and analysis
Analysis and problem solving skills
Quality orientation
Ability to effectively influence
Additional Information
8 hour days – Monday through Friday
Overtime may be required
Work in a dynamic and fast-paced environment
5 – 10% Travel Required
Applicant will work in various areas within the Parenteral Site. Some allergens are present.
Applicant will be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities. Mobility requirements should be considered when applying for this position
On call support may be required
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.
Compensation 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.
Benefits 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; life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits.
Seniority level Mid-Senior level
Employment type Full-time
Job function Research, Analyst, and Information Technology
Industries Internet News
#J-18808-Ljbffr
Organization 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 39,000 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 Brand Description The Scientist positions in the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS / MS – SAT) group are positions that provide support for control of the site’s manufacturing facilities. The group develops and implements sterility assurance related initiatives and provides technical leadership with regard to sterility assurance strategies.
Responsibilities
Ensure site’s Environmental Monitoring, Aseptic Process Simulations, Facility Cleaning, Facility Sanitization, Sterility Assurance Risk Management, and other sterility assurance programs are followed at the manufacturing Flow level.
Provide technical guidance to the Flow and Process Teams for sterility assurance programs.
Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
Lead or provide technical support for root cause investigations for sterility assurance programs.
Use of sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
Execute and assist in the development of process and facility monitoring strategies that focus on areas of highest microbial risk.
Lead site aseptic self-inspection program including communication of observations and recommendations for continuous improvement to manufacturing and support personnel.
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
Create, execute, review and/or approve technical documents related to sterility assurance programs including risk assessments, justification documents, protocols, and summary reports.
Create, execute and/or review change controls related to sterility assurance programs.
Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends.
Participate in continuous improvement projects to improve quality performance at the site.
Participate or provide guidance for sterility assurance programs during regulatory audits.
Provide content and/or data integrity reviews for regulatory submissions.
Lead training courses related to sterility assurance programs.
Basic Qualifications
Bachelor’s degree in Microbiology, Biology, or other STEM related discipline in conjunction with relevant experience.
Additional Skills/Preferences
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Understanding of GMPs and applicable internal standards
Parenteral Manufacturing experience
Communication (oral and written) skills; technical writing skills
Teamwork / interpersonal skills
Experience with data trending and analysis
Analysis and problem solving skills
Quality orientation
Ability to effectively influence
Additional Information
8 hour days – Monday through Friday
Overtime may be required
Work in a dynamic and fast-paced environment
5 – 10% Travel Required
Applicant will work in various areas within the Parenteral Site. Some allergens are present.
Applicant will be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities. Mobility requirements should be considered when applying for this position
On call support may be required
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.
Compensation 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.
Benefits 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; life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits.
Seniority level Mid-Senior level
Employment type Full-time
Job function Research, Analyst, and Information Technology
Industries Internet News
#J-18808-Ljbffr