Senior Manager- Project Engineering and CQV

Senior Manager
- Project Engineering and CQV

Join Bio Space (Lilly) as the Senior Manager responsible for Project Engineering and CQV at the Indianapolis Radioligand Therapy (IRLT) site. The role reports to the Site Engineering Leader and leads the strategy and execution of CQV for capital and site projects, ensuring regulatory compliance and operational readiness.

This position is located onsite at IRLT in Indianapolis, IN and is not approved for remote work. Requires up to 10% travel, project dependent.

The role focuses on defining and driving the CQV strategy, leading the project engineering team, and collaborating with cross‑functional partners such as Engineering, TSMS, Quality, and Operations. The incumbent will oversee equipment and workflow qualification, compliance with GMP and regulatory standards, and support IT system integration for data integrity.

• 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, including:
  • 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, promoting knowledge sharing and best practices across sites and disciplines.
• Serve as the site owner for the Kneat solution for electronic documentation of CQV activities, coordinating training and administration of the tool.
• Oversee preparation for regulatory inspections, corporate audits, and internal reviews, ensuring documentation and systems are inspection‑ready.
• Perform risk management: identification of 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 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.
• 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 preferred.
• Proficient in qualification and validation requirements for manufacturing equipment and process changes.
• Excellent verbal and written communication skills with technical or cross-functioning 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 (i.e., 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.

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