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Lilly Container Closure Engineer in Indianapolis, Indiana

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 35,000 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.

Responsibilities:

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 Container Closure Engineer (CCE), with a focus on oral products and shipping/distribution, leads the execution and documentation of packaging deliverables within a cross-functional CM&C team environment supporting each molecule-specific project in development for new product entities and line extensions. The CCE works closely with other functional areas including Project Management, Formulation, Analytical, Clinical Operations, Commercial Manufacturing, Regulatory, Quality, Materials Management, Human Factors, Systems Engineering, Device Design Engineering, Global Logistics and Secondary Packaging to enable project progression. Key deliverables for the CCE includes container closure selection (primary and critical secondary packaging), suitability evaluation to enable use of packaging components in clinical trials, and the execution of studies and documentation to enable successful pharmaceutical product regulatory submissions. Additional deliverables include delivering product distribution solutions, develops and maintains suitable packaging and distribution systems (including cold-chain shipping) to enable clinical development and tech transfer to manufacturing, including but not limited to cartons, labels and shipping containers for both drug substance and drug products.

Key Objectives / Deliverables:

The Container Closure Engineer will contribute to the development and launch of pharmaceutical products with the following responsibilities:

  • Represent DDCS in team meetings to communicate packaging strategy, shipping / distribution strategy, component / system properties, risks, timing, and cost.

  • Partner with key stakeholders (internal and external to Lilly) to enable project progression from clinical development through commercialization.

  • Support the authoring and technical review of regulatory submission documentation, container closure system suitability assessments, max stress, definitive and field shipping study protocols and reports as well as development history reports.

  • Stay abreast of regulatory and compendial requirements for packaging components, systems and testing requirements.

  • Conduct risk assessments to evaluate components, systems, suppliers, and processes.

  • Plan and execute key activities to support packaging design, selection, characterization testing, and system qualification for molecule-specific projects in accordance with quality system procedures and business practices.

  • Provide technical review for packaging component specifications and incoming release testing protocols.

  • Lead design efforts for packaging systems which require child resistance / senior friendliness testing. Work with DDCS Platform Engineers to enable child resistance testing.

  • Interface with DDCS Platform Engineers and/or suppliers to ensure project progression by obtaining components and documentation supporting component qualification and regulatory submissions (including LOA, DMF, etc.)

  • Assist Platform Engineers in evaluating the impact of supplier change notifications on molecule projects, packaging specifications, qualification, and regulatory commitments.

  • Interface with DDCS Platform Engineers and Lilly’s Product Delivery organization to achieve component availability for development, clinical, and commercial use to support products in development.

  • Communicate with DDCS Platform Engineers and external contractors to maintain material inventory, coordinate external testing of packaging components, and submit purchase orders for ordering and testing of development materials.

  • Partner with Extractables / Leachables and Toxicology colleagues to obtain safety assessments for packaging materials

  • Respond to regulatory feedback and submission questions related to container, component or shipping/distribution strategy

  • Explore ways to reduce shipping/distribution testing redundancy in DDCS and streamline shipping study strategies

  • Provide technical support for the evaluation and development of new packaging technologies and implement these container closure systems into molecule projects.

  • Ensure individual and departmental compliance with the laws, regulations, guidelines, procedures, and practices governing drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.

  • Ensure that people and their environment are safe and that company policies concerning safety and confidentiality are followed.

Basic Qualifications:

  • BS in Engineering, Packaging, Materials Science, Pharmaceutical Science, or related field.

  • 7+ years of experience working in the pharmaceutical, medical device, or packaging industries.

Additional Skills/Preferences:

  • Previous pharmaceutical packaging experience with oral drug products (tablets/capsules, powders, liquids) and/or oral packaging components (bottles, blisters, sachets, stickpacks, liners) a plus

  • Previous pharmaceutical experience in cold chain shipping strategy and requirements for parenteral products, containers, and devices a plus

  • Strong working knowledge of pharmaceutical industry regulatory directives, guidance, and compendial standards for packaging components, container closure systems and testing standards (i.e. ISTA, USP, PhEur, & JP)

  • Teamwork and leadership skills

  • Self-management skills with a focus on results for timely and accurate completion of competing deliverables

  • Strong technical writing skills and effective communication style

  • Strong technical problem-solving skills, strategic thinking, and demonstrated ability to identify problems and drive issue resolution / improvements

  • Materials Science background in glass, elastomers, or plastics a plus

  • Experience leading and / or participating in formal risk assessments (process / design) and integrating inputs / outputs into a risk management system

Additional Information:

  • Limited Travel may be required to Lilly sites globally.

  • This position is being offered as an onsite role and based in Indianapolis, IN. There is no current option for candidates that wish to work remotely or virtually.

Lilly 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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