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.
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
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.)
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
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
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