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Sterility Assurance Scientist/Engineer

Employer
Eli Lilly and Company
Location
Durham, North Carolina
Start date
Nov 13, 2023

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Discipline
Quality, Quality Assurance, Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.

The Scientist/Engineer – Sterility Assurance – Technical Services/Manufacturing Science (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies.

Primary objectives include the start-up and compliant manufacturing of RTP products, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management. The scope of the role includes syringe filling operations for commercially manufactured products targeted for transfer to the RTP site.

Responsibilities:

  • Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems

  • Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination

  • Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk

  • Provide technical support for all start-up activities related to sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)

  • 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 floor level

  • Provide technical guidance to the Process Team for sterility assurance programs

  • Lead or provide technical support for root cause investigations related to sterility assurance programs

  • Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements

  • Perform periodic review of environmental monitoring data

  • Lead or support risk assessments related to sterility assurance programs

  • Create, execute, review, and/or approve technical documents related to sterility assurance programs

  • Create, execute, and/or evaluate 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 internal and external audits, including regulatory inspections, as needed

  • Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda

  • Serve as sterility assurance interface external to the RTP site

  • Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives

  • Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain

  • Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

Basic Requirements:

  • BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

  • Experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services/MSAT, quality assurance, etc.)

Additional Preferences:

  • In depth knowledge of parenteral drug product manufacturing

  • Strong interpersonal and teamwork skills

  • Strong self-management and organizational skills

  • Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization

  • Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations

  • Demonstrated successful leadership of cross-functional teams

  • Experience with data trending and analysis

  • Ability to analyze complex data and solve problems

Other Information:

  • Role is Monday through Friday based.

  • 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

  • Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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