Associate Director - Project Engineering and CQV at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

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

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
Oversee qualification and validation activities including FAT, commissioning, and validation of equipment and workflows
Ensure all systems and equipment meet GMP and regulatory standards (FDA, EMA, etc.) from design through validation
Support IT system integration for data integrity
Align 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
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 through execution of FMEA and feasibility studies, 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

Skills

CQV

Commissioning

Qualification

Validation

FAT

Project Engineering

Capital Projects

Regulatory Compliance

Equipment Validation

Workflow Validation

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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