Principal Engineer - Parenteral Packaging R&D

Eli Lilly and Company • Indianapolis, IN

1d

About The Position

The Delivery, Device and Connected Solutions (DDCS) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems, including medical devices and container closure systems. This role is for a Principal Packaging Engineer to be a key contributor within the parenteral packaging team, part of the DDCS Packaging Organization. The position requires advanced technical expertise in parenteral packaging for drug product and Lilly’s combination products. The engineer will work collaboratively with CMC, drug product development, device design, manufacturing, and quality teams to ensure successful development and commercialization of Lilly drug products. As a vital contributor to CMC success, the candidate must be knowledgeable, highly energetic, and self-motivated, distinguishing themselves through capability, efficiency, safety, and continuous advancement in parenteral packaging and associated areas.

Requirements

• Bachelor's degree in engineering, packaging, materials science or pharmaceutical science or related field with 5+ years of experience in chemical, materials, biomedical, packaging engineering or relevant field.
• Previous experience with combination products, drug delivery device, container closure system and/or primary packaging.
• Experience in working effectively with cross functional groups.
• Solid understanding of basic requirements of regulatory agencies.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Master's degree in engineering, packaging, materials science or pharmaceutical science or related field with 3+ years of experience in chemical, materials, biomedical, packaging engineering or related fields.
• Familiarity with Quality By Design (QbD) and ICH guidelines.
• Previous parenteral packaging qualification experience.
• Demonstrated ability to influence and operate cross-functionally.

Responsibilities

• Lead selection, development, assessment and qualification of container closure systems including vials, prefilled syringes and cartridges, throughout Lilly's new drug product development cycle for commercialization.
• Collaborate with formulation and analytical chemistry partners to perform mechanistic research and develop a robust understanding of key physical and chemical properties of packaging materials and their interactions with drug products.
• Ensure container closure systems’ safety, protection, compatibility, and functionality attributes meet drug product and drug substance’s requirements.
• Apply scientific principles and problem-solving approaches to advance fundamental understanding of complex challenges and develop innovative packaging solutions that enable drug product safety and efficacy.
• Work with internal and external subject matter experts (SMEs) to evaluate and develop new test methods for container closure qualification and establish robust control strategies.
• Partner with parenteral filling SMEs, external component suppliers, CDMOs, and OEMs to design and implement de-risked, viable filling processes for parenteral packaging components supporting clinical trials and potential commercial manufacturing.
• Prepare and support technical documentation, including protocols and reports, for parenteral drug product process development.
• Ensure technical soundness and quality of regulatory submission packages, including comprehensive control strategies and supporting rationale.
• Collaborate with external suppliers to define specifications for packaging components and systems.
• Collaborate with data science SME to adopt and apply artificial intelligence technology to accelerate packaging development and risk mitigation solutions.
• Drive technology innovation by exploring, identifying, and delivering new solutions to the parenteral packaging network; evaluate and prioritize emerging technologies for current and future applications.
• Provide technical leadership for team, departmental, and corporate initiatives, including due diligence activities related to parenteral packaging solutions.
• Enhance Lilly’s professional reputation and competitive advantage through presentations, external conferences, publications, and other professional engagements.

Benefits

• Company bonus (depending, in part, on company and individual performance).
• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees