Scientist - TS/MS - Sterility Assurance Technology at Lilly

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

171600.0

Posted On

08 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, Biology, GMPs, Technical Writing, Teamwork, Data Trending, Analysis, Problem Solving, Quality Orientation, Influencing, Aseptic Certification, Environmental Monitoring, Sterility Assurance, Root Cause Investigation, Continuous Improvement, Regulatory Compliance

Industry

Pharmaceutical Manufacturing

Description

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. #WeAreLilly 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. 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. #WeAreLilly

Responsibilities

The Scientist will ensure compliance with sterility assurance programs and provide technical guidance to teams. Responsibilities include leading investigations, analyzing data, and developing monitoring strategies.