Associate Director - Validation TS/MS (m/f/d)

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 next decades, with direct visibility to site leadership and Lilly's global technical network.

Key Objectives / Deliverables:

• Responsible for maintaining a safe work environment, working safely and accountable to support all HSE corporate and site goals.
• Building and leading a team in alignment with the Lilly values to support initial and revalidation of the process
• Fully accountable for planning execution of sterilization validation, cleaning validation, filter validation, shipping validation, temperature mapping and other validations.
• Build robust systems for revalidation incl. Coordination with stakeholders as engineering, operations and quality
• Ensure correct governance to steer validation activities. Manage stakeholders incl. leadership team and align with operational planning
• Coach team to increase maturity and support technical development
• Own validation concepts and ensure alignment within the network
• Manage investigations of complex validation deviations related to cleaning, sterilization, filtration, and temperature mapping and give guidance to the extended team to manage product impact assessments
• Prepare and provide technical review of completed/executed validation packages by compiling and analysing validation data
• Manage external contracts/resources and project management resources, as needed.
• Present validation related topics during health authority inspections
• Maintain an up-to-date knowledge of validation requirements, industry best-practices, and benchmark within the Lilly network

Expected Qualifications:

• 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
• Strong knowledge of risk management and understanding / ability to use risk assessment tools as part of a validation strategy
• Ability to analyse complex data and solve problems
• Strong technical writing and presentation skills
• Fluent in English
• English Resume only please

Additional Preferences:

• 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.)
• Able to communicate in German

What to consider:

• Role is Monday through Friday site-based (Alzey) with the ability to travel to Indianapolis and other global Lilly sites as required.
• Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.