Lead Secondary Packaging Development Engineer

BioSpace; Indianapolis (IN); On-site; USD 64,500 - 167,200; Full time

Benefits offered by this job

Comprehensive benefits program

Retirement savings plan

Company bonus

Job summary

A global healthcare leader in Indianapolis is seeking a Lead Secondary Packaging Development Engineer to innovate and qualify secondary packaging solutions for pharmaceuticals. You will work within a dynamic team to ensure compliance with regulations and drive patient-centered design. The ideal candidate has significant experience in packaging engineering, particularly within GMP-regulated environments. This role offers competitive salary, benefits, and the chance to impact patient care.

Qualifications

• Minimum of 7 years of experience in packaging engineering and shipping distribution.
• At least 2 years of experience in GMP-regulated industries required.
• Background in sterile barrier and/or deep frozen product packaging.

Responsibilities

• Drive patient-centered packaging design requirements.
• Design and qualify secondary packaging structures.
• Complete documentation for tech transfer and regulatory submissions.

Skills

Technical problem solving

Project management

Cross-functional team leadership

Knowledge of GMP

Education

Bachelor’s degree in engineering or science

Master’s degree in engineering or science

Job description

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’re looking for people who are determined to make life better for people around the world.

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 against 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, and qualify secondary packaging structures (carton, tray, printed materials, labels, and adhesives) 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 related packing/shipping processes to enable product distribution in clinical environments and commercial launches.
• Develop suitability rationale for secondary packaging and shipping.
• Complete appropriate documentation to support tech transfer and regulatory submissions.
• Assess engineering risk for secondary packaging and shipping (e.g., DFMEA, AFMEA).
• Define and establish control strategy elements, including specifications and inspection/testing procedures.
• Mentor lower level engineers and contingent workers.
• Drive packaging related technical engineering agenda items and process improvements.
• Incorporate technical advancements and innovations into the current portfolio 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.
• 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 (e.g., 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.

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.
• Stay current in the latest developments in packaging for the pharmaceutical industry.

Basic Qualifications

• Bachelor’s degree in engineering or science, with a minimum of 7 years of work experience in both packaging engineering and shipping distribution, OR a Master’s degree with a minimum of 4 years in packaging engineering and shipping distribution.
• 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.
• Effective project management skills and ability to respond to changing priorities and short lead times.

Lilly is an equal opportunity employer committed to accommodating applicants with disabilities. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly HR for assistance. We encourage applicants to request accommodation as part of the application process. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities for vying for positions. This includes an accommodation request form available at the Lilly workplace accommodation site. 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.

Actual compensation will depend on a candidate’s education, experience, skills, and location. The anticipated wage for this position is $64,500 - $167,200. Full-time employees are eligible for a company bonus and a comprehensive benefits program, including 401(k), pension, vacation, medical, dental, vision, and other benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion.