Senior Packaging Engineer - Drug Product Development (Biologics & Pharma)

About the Role As a Senior Packaging Engineer – Drug Product Development, you will lead the design, development, and implementation of packaging solutions supporting Elanco’s global pipeline. This role focuses on pharmaceutical, biologics, and vaccine products, partnering across R&D, Manufacturing, Quality, and Regulatory to bring therapies from development through commercialization. You will own packaging strategy and execution for assigned programs, ensuring solutions meet performance, regulatory, and manufacturability requirements. This is a high-impact role for a packaging engineer who thrives in a GMP-regulated, cross-functional environment and wants end-to-end ownership. Your Responsibilities Lead primary, secondary, and tertiary packaging development from early-stage design through commercialization Serve as the packaging Subject Matter Expert (SME) on cross-functional drug product development teams Support sterile and non-sterile packaging systems, including parenteral packaging formats Partner with R&D and Manufacturing to assess technical feasibility, scalability, and process transfer to commercial production Design and execute packaging studies, validation activities, and equipment trials, analyzing data to drive decisions Author and support regulatory documentation and submissions, including packaging sections for global filings Evaluate and qualify packaging materials, components, and suppliers to ensure quality, compliance, and supply continuity Ensure alignment with GMP, FDA, EMA, and global regulatory requirements Collaborate with global teams and external partners to meet development timelines and program milestones What You Need to Succeed (Minimum Qualifications) Bachelor’s or Master’s degree in Packaging Engineering, Packaging Science, or related field 5+ years of experience in pharmaceutical, biopharmaceutical, or vaccine drug product development Experience with sterile/parenteral packaging systems and associated regulatory expectations Strong knowledge of packaging materials, container closure systems, and pharmaceutical manufacturing processes Working knowledge of GMP and regulated development environments Proven ability to operate in cross‑functional, global teams with strong communication skills What Will Give You a Competitive Edge (Preferred Qualifications) Experience supporting biologics, vaccines, or combination products Knowledge of Container Closure Integrity (CCI), extractables/leachables, and stability requirements Experience authoring or contributing to IND, BLA, or global regulatory submissions Background in technology transfer and scale-up into commercial manufacturing Ability to manage multiple development programs in a fast‑paced environment Additional Information Location: Indianapolis, IN (Hybrid) Travel: 10–20% Elanco Benefits and Perks Multiple relocation packages Two weeklong shutdowns (mid‑summer and year‑end) in the US (in addition to PTO) 8‑week parental leave 9 Employee Resource Groups Annual bonus offering Flexible work arrangements Up to 6% 401K matching Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice. #J-18808-Ljbffr Elanco