Senior​/Principal Scientist Validation

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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

As Principal Scientist Validation, you will be expected to instruct and support the validation of production equipment and systems.

• Sterilization validation
• Cleaning validation
• Filter validation
• Shipping validation
• Process validation
• Other TS/MS related activity

Prepare, review relevant technical documents, as required, such as:

• Change controls
• Regulatory submissions
• Deviation investigations
• Validation protocols and summary reports
• Processing records
• Procedures

Participate in development and implementation of process functional teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.

Initiate related validation protocols and reports, and coordinate validation related activities.

Complete required and assigned trainings on-time.

Instruct and support validation of production equipment and systems. Prepare, review and support relevant technical documents. Execute validation related activities. Ensure compliance with the final objective and coordinate with local project team.

Degree/qualifying certifications/training/experience:
Engineer, pharmacist, or equivalent with professional experience (at least 5 years) in the industry. Knowledge of GMP Operation skills. Good knowledge of document and project management. You have German and basic English knowledge.

• Parenteral manufacturing
• Strong analytical and synthesis skills
• Excellent interpersonal and communication skills
• Ability to work independently and in a team
• Abili…