Senior Manager- Project Engineering and CQV

Senior Manager
- Project Engineering and CQV

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 Phase 3 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 and other site projects.

• 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 equipment and workflows.
  • Compliance:
    Ensure that all systems and equipment meet GMP and regulatory standards (FDA, EMA, etc.) from design through validation.
  • Support for IT system integration for data integrity.
  • Alignment with Lilly’s global approach for manufacturing equipment and systems used in radiopharmaceutical production.
  • Collaborate with cross‑functional teams including Engineering, TSMS, Quality, and operations to support CQV/PE deliverables.
• Translate business objectives into executable CQV and project engineering plans that support product lifecycle milestones and commercialization timelines.
• Act as a mentor and technical resource for junior engineers and cross‑functional teams. Promote knowledge sharing and best practices across sites and disciplines.
• Be the site owner of the Kneat solution for electronic documentation of CQV activities, including coordinating training and administration of the tool.
• Oversee preparation for regulatory inspections, corporate audits, and internal reviews, ensuring documentation and systems are inspection‑ready.
• Risk Management:
  
  Identify technical risks and mitigation planning for the CQV approach at the site.
• Lead and/or support the development and execution of FAT, commissioning and validation of equipment and process workflows in alignment with TS/MS and Engineering needs.
• Drive optimization and compliance with their knowledge with execution of FMEA and feasibility studies and basic process flow development and optimization.
• Document technical work through formal reports and participate in technical presentations.
• Support continuous improvement initiatives to enhance equipment reliability and process efficiency.
• Participate in mentoring and sharing knowledge with peers and junior staff.
• Maintain the site agenda and planning for CQV/Project Engineering activities.

• Minimum Bachelor’s degree in Engineering or Science related degree.
• 5+ years’ experience working in an FDA regulated operation including at least 2–3 years’ experience in CQV.

• Experience working with small‑volume parenteral, sterile unit‑dose filling, or radiopharmaceutical drug products.
• Proficient in qualification and validation requirements for manufacturing equipment and process changes.
• Excellent verbal and written communications skills with technical or cross‑functional audiences, and proven ability to work independently with external suppliers.
• Manufacturing process development or operations experience with process flow design, manufacturing line design, development and implementation, process automation, and software validation.
• Process DOE execution (e.g., manufacturing process optimization, assembly process development/characterization/qualification).
• Understanding of vision‑based inspection methods.
• Experience with FMEA, process flow development, applying the design control process, equipment development and external manufacturing & supplier management.
• Requires up to 10% travel, project dependent.

This position is located onsite in Indianapolis, IN at our Radioligand Therapies site and is not approved for remote work.

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