Associate Director - Project Engineering and CQV

Role Summary

Associate Director - Project Engineering and CQV responsible for strategy and execution of the CQV approach at the site, leading the project engineering team for major capital and other site projects. Located at the Indianapolis Radioligand Therapy site; reports to Senior Director of Engineering.

Responsibilities

• Define and drive the Commissioning, Qualification and Validation (CQV) strategy and leadership of the project engineering team 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‚Äôs 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.
• Mentor and provide technical resources for junior engineers and cross-functional teams; promote knowledge sharing and best practices.
• 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 knowledge 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.
• Mentor and share knowledge with peers and junior staff; maintain the site agenda and planning for CQV/Project Engineering activities.

Qualifications

• Minimum Bachelor‚Äôs degree in Engineering or Science related field.
• 5+ years experience in a FDA-regulated operation with extensive knowledge of cGMPs and CQV activities.
• Proficient in qualification and validation requirements for manufacturing equipment and process changes.

Skills

• Experience with small-volume parenteral, sterile unit-dose filling, or radiopharmaceutical products (preferred).
• Excellent verbal and written communications skills with technical or cross-functional audiences; 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 (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.
• Travel up to 10% depending on project needs.

Education

• Bachelor‚Äôs degree in Engineering or Science related field.

Additional Requirements

• This position is onsite in Indianapolis, IN at the Radioligand Therapies site; not remote.
• Ability to travel up to 10% as required by projects.