Lead Secondary Packaging Development Engineer

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism

Organization 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 packaging systems. The DDCS organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables almost $4.0 billion in pharmaceutical sales and continues to grow.

DDCS supports the design, development, and commercialization of medical devices and owns the development and qualification of drug substance (API) and drug product packaging components and container closure systems. The Secondary Packaging Development Engineer has the responsibility for the development, qualification, and implementation of secondary packaging solutions and processes in support of development of new pharmaceutical products, delivery devices, and/or drug-device combination products, with emphasis on patient-centered design.

The responsibilities also include developing suitable product distribution solutions to ensure adequate product protection during shipping again mechanical and thermal (for cold-chain products) hazards.

Responsibilities:

* Partner with Device development, Business Unit, and Human Factor teams to drive patient-centered packaging design requirements.

* Design, develop, & qualify secondary packaging structures (carton, tray, printed materials, labels, and adhesives etc.) to enable Lilly's clinical portfolio development and product launch.

* Define and verify product stability requirements against shipping hazards such as vibration, shock, vacuum, and thermal stresses.

* Develop and qualify shipping containers and associated packing/shipping processes to enable product distribution in clinical environment and commercial launches.

* Develop suitability rationale for secondary packaging and shipping;

* Complete appropriate documentation to support tech and knowledge transfer and regulatory submissions.

* Assess engineering risk for secondary packaging and shipping (e.g. DFMEA, AFMEA).

* Define and establish control strategy elements such specifications and inspection/testing procedures.

* Mentor lower level engineers and contingent workers

* Drive packaging related technical engineering tech agenda items and process improvements

* Incorporate technical advancements and innovations into the current portfolio as appropriate to meet the growing needs of novel drugs and devices.

Compliance:

* Provide regulatory submission support

* Ensure work products are compliant with applicable standards (e.g. USP, EP, JP, CFR, ASTM, ISTA).

* Ensure timely review/approval of methods, departures, procedures, protocols, and changes, etc.

* Ensure appropriate safety practices and procedures are followed to prevent injuries.

Customer Service:

* Maintain close partnership with key development customers to integrate package development deliverables into mainstream product development for both small molecules and bioproducts (i.e. the single process map).

* Maintain close partnership with key development, marketing, and manufacturing customers to ensure clear requirements definition and effective transfer of new products for commercialization.

* Maintain close partnership with packaging-related groups, including New Product Planning, Clinical Trial Mfg/Pkg, Global Packaging, Mfg/Pkg Sites, and TS/MS.

* Participate in the corporate procurement strategy for packaging components.

Technical Excellence:

* Ensure reliable delivery of robust technically sound work products (regulatory modules, technical reports, qualification reports, development history reports, process flow documents, engineering risk assessments, etc.).

* Participate in engineering due diligence for suppliers and CMOs.

* Monitor progress of new technology and patient-centered design initiatives.

* Encourage the application of package evaluation techniques to solve problems.

* Ensure stays current in the latest developments in…