Lead Secondary Packaging Development Engineer jobs in United States
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Eli Lilly and Company · 5 hours ago

Lead Secondary Packaging Development Engineer

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, committed to discovering and delivering life-changing medicines. The Lead Secondary Packaging Development Engineer is responsible for developing and qualifying secondary packaging solutions for new pharmaceutical products and ensuring product protection during distribution.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

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
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
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
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

Qualification

Packaging engineeringShipping distributionGMP complianceTechnical problem solvingProject managementPatient-centered designRisk assessmentCross-functional leadershipTechnical report writing

Required

Bachelor's degree in engineering or science, with a minimum of 7 years work experience in both packaging engineering and shipping distribution field OR Master's 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

Preferred

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

Benefits

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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Company

Eli Lilly and Company

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We're a medicine company turning science into healing to make life better for people around the world.

H1B Sponsorship

Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)

Funding

Current Stage
Public Company
Total Funding
$6.5M
2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO

Leadership Team

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David Ricks
Chair, CEO
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Lucas Montarce
Executive Vice President and Chief Financial Officer
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Company data provided by crunchbase