Engineer - Parenteral Packaging - Packaging System Solutions

Eli Lilly and Company • Indianapolis, IN

2d • $65,250 - $169,400

About The Position

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 and Position Overview: 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. We are seeking a Packaging Engineer to be a key contributor within our parenteral packaging team, part of DDCS Packaging Organization, offering advanced technical expertise in the field of parenteral packaging and Lilly’s combination product. This role demands established skillset and knowledge in parenteral packaging for drug product, working 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. The person must distinguish him- or herself through capability, efficiency, safety and continuous advancement in parenteral packaging and associated area.

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, or PhD with 1+ year of experience.
• 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

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level