Lilly
Healthcare
AssociateDirector-ValidationTS/MS(m/f/d)
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“Associate Director - Validation TS/MS (m/f/d) at Lilly. Skills: Validation, Process robustness, Team leadership. Maintain a safe work environment. Support all HSE corporate and site goals”
Industry & Context.
Solve problems; Analyse complex data; Manage investigations; Root cause analysis
Travel to Indianapolis, Travel to global Lilly sites, Flexibility in providing support
What They're Looking For.
Must Have
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline, Understanding of GMPs and manufacturing processes, Experience in building and leading a team, Extensive knowledge with equipment qualification and/or cleaning, decontamination, sterilization process validation, Knowledge of risk management, Ability to analyse complex data and solve problems, Technical writing and presentation skills, Fluent in English
Nice to Have
Prior experience in multiple functions associated with manufacture of parenteral products, Able to communicate in German
What You'll Do.
Maintain a safe work environment
Support all HSE corporate and site goals
Build and lead a team
Support initial and revalidation of the process
Plan execution of sterilization validation
Plan execution of cleaning validation
Plan execution of filter validation
Plan execution of shipping validation
Plan execution of temperature mapping
Plan execution of other validations
Build robust systems for revalidation
Coordinate with stakeholders
Ensure correct governance to steer validation activities
Align with operational planning
Coach team to increase maturity
Support technical development
Own validation concepts
Ensure alignment within the network
Manage investigations of complex validation deviations
Give guidance to the extended team
Manage product impact assessments
Prepare technical review of validation packages
Compile validation data
Analyse validation data
Manage external contracts
Manage project management resources
Present validation topics during health authority inspections
Maintain up-to-date knowledge of validation requirements
Maintain up-to-date knowledge of industry best-practices
Benchmark within the Lilly network
How You'll Work.
Team & Collaboration
Coordination with stakeholders; Alignment within the network; Guidance to the extended team
Communication Scope
Presentation skills; Technical review
Process & Methodology
Project management
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. 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 **TS/MS (Technical Services / Manufacturing Science)** team (also known as MSAT or MS&T). The TS/MS 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 runs for the nex
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