Scientist – Sterility Assurance - Technical Services​/Manufacturing Science; m​/w​/d

Position: Scientist – Sterility Assurance - Technical Services/Manufacturing Science (m/w/d)
Location: Germany

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.

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.

At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People."
** Join our Lilly team in Alzey and start as soon as possible as:
**** Scientist – Sterility Assurance - Technical Services/Manufacturing Science (m/w/d)
**** Responsibilities:
** The Sterility Assurance Scientist is a technical role that assists in development and implementation of the site’s sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team.  

The principal role is also expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to sterility assurance.
** Key Objectives/Deliverables:*** (Associate/Senior) Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.
* Lead or provide technical oversight for Provide technical support for activities related to sterility assurance programs including but not limited to:  + Airflow Pattern Testing  + Environmental Monitoring Performance Qualifications  + Aseptic Process Simulations  + Cleaning, Sanitization, and Disinfection  + Gowning within GMP Classified Areas  + Aseptic Processing Techniques  + Contamination Control
* Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.* (Senior) Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.* (Senior) Lead/assist with support and/or provide technical expertise for developing the site’s contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies.
* (Senior) Lead/assist with support and/or provide technical expertise  for the facility’s cleanroom gowning and aseptic technique strategy/program.* (Principal) Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification.* (Principal) Lead/provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program:  + (EM) Authoring EM Performance Qualifications (EM PQ) and overseeing the execution.  

+ (EM)…