- Understand the scientific principles required for manufacturing parenteral drug products, including a thorough knowledge of aseptic processing, aseptic process simulations, environmental monitoring, container closure systems, and contamination control strategies.
- 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, aseptic process simulations, etc.)
- 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.
- Ensure adherence to site's environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs.
- Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk.
- Lead or support risk assessments related to aseptic processing, environmental monitoring, and contamination control.
- Provide technical guidance and oversight of aseptic processing to the site Process Team.
- 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.
- Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs.
- 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.
- Collaborate with cross-functional teams to develop and implement TS/MS objectives and deliver on business plan and quality objectives.
- Network with teams across the Parenteral Network on sterility assurance objectives to harmonize global aseptic standards and contamination control.
- 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.
- 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 with parenteral drug product manufacturing
- Experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services/MSAT, quality assurance, etc.) Additional Skills/Preferences:
- 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
- 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 Additional 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 ( ) 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 -
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Scientist/Engineer – Sterility Assurance – Technical Services/Manufacturing Science - Durham, United States - Eli Lilly and Company
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.
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.
Key Objectives / Deliverables:
