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. Were 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 Lillys 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 packaging for the pharmaceutical industry.

Basic Qualifications:

• Bachelors degree in engineering or science, with a minimum of 7 years work experience in both packaging engineering and shipping distribution field OR Masters degree in engineering or science, with a minimum of 4 years work experience in both packaging engineering and shipping distribution field
• A minimum of 2 years of work experience in GMP regulated pharmaceutical and/or medical device industries is required.
• Background in sterile barrier and/or deep frozen product packaging

Additional Skills/Preferences:

• Strong technical problem solving with emphasis on patient/consumer-centered design, package functionality, and manufacturability
• Broad integrated technical knowledge for system and design engineering, product development, and commercialization of pharmaceuticals, medical devices, container closure systems.
• Demonstrated ability to lead cross-functional teams
• Individual must demonstrate effective project management skills and be able to respond to changing priorities and short lead times

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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