Lilly
healthcare
SiteSterilitySteward
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Site Sterility Steward at Lilly. Skills: sterility assurance, risk management, parenteral processing, microbiology. maintaining a safe work environment. working safely”
What You'll Achieve.
ensure the supply of Lilly medicines in Germany, Europe, and worldwide; shape how this greenfield parenteral site runs for the next decades
Industry & Context.
Ability to analyze complex data and solve problems; Lead major deviations for root cause analysis related to sterility assurance programs
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, Occasional travel to Indianapolis and other global Lilly sites as required
What They're Looking For.
Must Have
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline, In depth knowledge and understanding of GMPs and internal standards, In depth knowledge of parenteral processing, In depth knowledge of microbiology and sterility assurance, In depth knowledge of risk management and the understanding / ability to use risk assessment tools, Ability to analyze complex data and solve problems, technical writing and presentation skills, Teamwork / interpersonal skills ability to effectively influence, Minimum 7 years’ experience in the biopharmaceutical industry
Nice to Have
Advanced Degree in Microbiology, Biology or related scientific field (or equivalent work experience), Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations, Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)
What You'll Do.
maintaining a safe work environment
supporting all HSE Corporate and Site Goals
understanding the scientific principles required for manufacturing parenteral drug products
using sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls
leading and / or participating in complex projects associated with sterility assurance programs
leading and / or assisting in the development and execution of process and facility monitoring strategies
leading major deviations for root cause analysis related to sterility assurance programs
remaining abreast of external regulatory requirements associated with sterility assurance programs
influencing revision to corporate guidance associated with sterility assurance programs
identifying and implementing continuous improvement for sterility assurance programs
providing design input related to new processes
representing and defending the site’s sterility assurance programs during internal audits and external regulatory inspections
assisting with writing of regulatory submissions for sterility assurance programs
approving and providing sterility assurance training for new hires and personnel from other sites
How You'll Work.
Team & Collaboration
Provide technical mentorship to a less senior scientists within the TS/MS organization; Provide technical mentorship to a less senior cross-functional personnel within Alzey; Provide technical consultation across the Parenteral Network
Communication Scope
technical writing and presentation skills
Process & Methodology
Lead and / or participate in complex projects associated with sterility assurance programs
Full Job 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. **Position 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. 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." In this role you will be part of the TSMS (Technical Services / Manufacturing Science) team (also known as MSAT or MS&T). The TSMS team is the technical owner of the process — from tech transfer and validation through commercial lifecycle management. Our decisions on control strategy, lifecycle, and process robustness shape how this greenfield parenteral site
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