Associate Director - 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 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.

Organization Overview: 

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.

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 Sr Director of Engineering, this is 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.

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 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.  This includes 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: 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 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 Requirements:

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

Additional Skills/Preferences:

• Experience working with small-volume parenteral, sterile unit-dose filling, or radiopharmaceutical drug products preferred
• 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 (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
• 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$118,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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