Eli Lilly and Company
Associate Director - Project Engineering and CQV
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Associate Director - Project Engineering and CQV
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Associate Director - Project Engineering and CQV
role at
Eli Lilly and Company
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 work to discover and bring life‑changing medicines, improve disease understanding, and give back through philanthropy and volunteerism. We put people first and are looking for leaders determined to make life better for people worldwide.
This role is at the Indianapolis Radioligand Therapy (IRLT) site and 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 Sr. Director of Engineering, this leadership position oversees the CQV strategy and directs the project engineering team on major capital and other site projects.
Responsibilities
Define and drive the Commissioning, Qualification, and Validation (CQV) strategy and lead the project engineering team at IRLT, aligning with corporate goals, regulatory expectations, and operational readiness. This includes:
Qualification and Validation Activities: FAT, commissioning, and validation of equipment and workflows.
Compliance: Ensure 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.
Own 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.
Manage risk identification 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, executing FMEA and feasibility studies and basic process flow development and optimization.
Document technical work through formal reports and technical presentations.
Support continuous improvement initiatives to enhance equipment reliability and process efficiency.
Participate in mentoring and knowledge sharing with peers and junior staff.
Maintain the site agenda and planning for CQV/Project Engineering activities.
Qualifications
Minimum bachelor’s degree in Engineering or a related Science discipline.
5+ years of experience working in an FDA‑regulated operation with extensive knowledge of cGMPs and CQV activities.
Proficiency in qualification and validation requirements for manufacturing equipment and process changes.
Additional Skills and Preferences
Experience with small‑volume parenteral, sterile unit‑dose filling, or radiopharmaceutical drugs.
Excellent verbal and written communication 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.
Location and Travel This position is located onsite in Indianapolis, IN at our Radioligand Therapies site and is not approved for remote work.
Accommodation and EEO Statement Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. 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).
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.
Compensation 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 per year.
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Associate Director - Project Engineering and CQV
role at
Eli Lilly and Company
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 work to discover and bring life‑changing medicines, improve disease understanding, and give back through philanthropy and volunteerism. We put people first and are looking for leaders determined to make life better for people worldwide.
This role is at the Indianapolis Radioligand Therapy (IRLT) site and 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 Sr. Director of Engineering, this leadership position oversees the CQV strategy and directs the project engineering team on major capital and other site projects.
Responsibilities
Define and drive the Commissioning, Qualification, and Validation (CQV) strategy and lead the project engineering team at IRLT, aligning with corporate goals, regulatory expectations, and operational readiness. This includes:
Qualification and Validation Activities: FAT, commissioning, and validation of equipment and workflows.
Compliance: Ensure 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.
Own 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.
Manage risk identification 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, executing FMEA and feasibility studies and basic process flow development and optimization.
Document technical work through formal reports and technical presentations.
Support continuous improvement initiatives to enhance equipment reliability and process efficiency.
Participate in mentoring and knowledge sharing with peers and junior staff.
Maintain the site agenda and planning for CQV/Project Engineering activities.
Qualifications
Minimum bachelor’s degree in Engineering or a related Science discipline.
5+ years of experience working in an FDA‑regulated operation with extensive knowledge of cGMPs and CQV activities.
Proficiency in qualification and validation requirements for manufacturing equipment and process changes.
Additional Skills and Preferences
Experience with small‑volume parenteral, sterile unit‑dose filling, or radiopharmaceutical drugs.
Excellent verbal and written communication 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.
Location and Travel This position is located onsite in Indianapolis, IN at our Radioligand Therapies site and is not approved for remote work.
Accommodation and EEO Statement Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. 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).
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.
Compensation 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 per year.
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