Engineer, Cold Chain Packaging/Distribution | Eli Lilly | Indianapolis, IN
The Global Packaging group is responsible for providing engineering and technical support for Lilly commercial packaging operations worldwide. The group is also responsible for integration with the development organization as it relates to the delivery of packaging for new molecules and line extensions.
The Distribution Engineer develops, qualifies, and optimizes shipping container systems for all existing and new pharmaceutical products. The position also assists in the development of new package technologies (materials, methods, or equipment) for Lilly products. The packaging engineer also routinely interfaces with Global Logistics and Site/Affiliate engineering resources and process teams. Key customers of the Packaging Engineer include Global Logistics, Product Development, Supply Chain, Manufacturing, Distribution, Quality Assurance, Regulatory, and Project Management and international/domestic Lilly Affiliates.
The engineer develops, qualifies, and optimizes shipping container systems for all existing and new pharmaceutical products. The position also assists in the development of new package technologies (materials, methods, or equipment) for Lilly products. The engineer also routinely interfaces with Global Logistics and Site/Affiliate engineering resources and process teams. Key customers of the Engineer include Global Logistics, Product Development, Supply Chain, Manufacturing, Distribution, Quality Assurance, Regulatory, and Project Management and international/domestic Lilly Affiliates.
1. Design/Improve Packaging/Shipping Technology – Cold Chain/Temperature Sensitive
- Identify and champion packaging system improvements that improve shipping economics (lower cost, equal or better performance)
- Identify packaging to improve product protection (compliance)opportunities to improve product protection, cost and compliance
- Stay abreast of industry trends and explore new materials, methods, and improved packaging processes
- Develop and implement a packaging strategy for continuous quality improvement of domestic product shipping Participate in industry groups/forums that address quality issues related to packaging/shipping pharmaceuticals
- Provide technical leadership to Distribution, Global Logistics LT as well as Domestic/International Lilly Affiliates.
- Provide technical guidance (consulting) to Lilly affiliates with respect to temperature-controlled packaging.
- Develop domestic and international ambient temperature profiles for Refrigerated and CRT product shipment package development.
- Conduct distribution testing for package configurations
- Coordinate harmonization/standardization efforts with domestic and international Lilly affiliates
- Provide Industry technical leadership for continuous improvement efforts.
2. Bench mark with other Pharma companies to understand synergies within temperature controlled shipping
- Engage with upstream marketing, development, and manufacturing to influence packaging design
- Develop specifications and drawings
- Interface with vendors, procurement, Incoming Materials QC
- Optimize current shipping processes and procedures
- Develop and implement shipping lane studies for current finished products
- Develop and implement a robust temperature-monitoring program for carrier and small packages.
3. Packaging Stability and Regulatory
- Design package screening studies
- Recommend package for temperature control, finished product stability
- Apply packaging laws and guidance
- Apply packaging specifications, qualification process, product/package stability, and data evaluation
- Apply and follow laws, regulations, and guidance applicable to pharmaceutical industry.
4. Project Leadership
- Provide accurate and timely documentation of work
- Ensure communication and on-time deliverables for assigned projects
5. Global Distribution SME
- Provide technical expertise/guidance for all containers and modes of transportation used including Temperature-Controlled Trucks, Active-Air Containers, Active-Ocean Containers, etc.
6. New Product Submission Support
- Conduct shipping studies to support global regulatory submissions
- Support new product launch at the Lilly sites
- Support post-approval changes and improvement projects
- Develop databases on all modes of transportation for temperature, pressure, shock, and vibration.
- Bachelor of Science Degree in Engineering, Logistics, or related field
- Minimum 3 years experience supporting packaging/distribution operations in a cold chain environment.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Project leadership
- Product development experience
- Knowledge of technology advances in packaging
- Experience with active pharmaceutical ingredient (API) and drug product
- Experience in a cGMP setting
- Proven communication and cGMP documentation skills
- Ability to effectively and appropriately influence team members at various levels in the organization
- Strong communication and teamwork skills
- Intermediate to advanced computer skills, particularly with Microsoft Office
- Project management experience