Senior Manager- Project Engineering and CQV

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. 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 around the world.

Position

Description:

This role is at Indianapolis Radioligand Therapy site in Indianapolis. The site is responsible for the commercial launch of RLTs, Supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches. Reporting to the Site Engineering Leader, this leadership position is responsible for the strategy and execution of the CQV approach at the site as well as leading the project engineering team for major capital andother site projects.

Job Responsibilities:

• Define and drive the Commissioning, Qualification and Validation (CQV) strategy and leadership of the project engineering team at IRLT aligned with corporate goals, regulatory expectations, and operational readiness. This includes:
  • Qualification and Validation
    
    Activities:
    
    FAT,commissioning,and validation of equipmentandworkflows.
  • Compliance:
    
    Ensure that all systems and equipment meet GMP and regulatory standards (FDA, EMA, etc.) from design throughvalidation.
  • Support for ITsystemintegration for data integrity.
  • Alignment with Lilly’sglobalapproachformanufacturingequipmentandsystemsusedinradiopharmaceuticalproduction.
  • Collaboratewithcross-functionalteamsincluding
    
    Engineering,TSMS,Quality,and operations to support CQV/PEdeliverables.