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.

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

Requirements

• 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

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
• Able to manage multiple development programs in a fast-paced environment