Sr. Packaging Engineer II - Cold Chain jobs in United States
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Gilead Sciences · 10 hours ago

Sr. Packaging Engineer II - Cold Chain

Gilead Sciences is dedicated to creating a healthier world for all people through innovative therapies. As a Senior Packaging Engineer, you will focus on the development and lifecycle management of temperature-controlled packaging systems, ensuring product integrity and compliance throughout global distribution.

BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Lead the design and qualification of thermal protection systems, collaborating with internal stakeholders (e.g., Quality, Regulatory, Supply Chain, Analytical Ops.) and external partners to ensure robust, compliant solutions
Execute simulated and real-time shipping qualifications and thermal mapping studies, ensuring compliance with global regulatory expectations
Author technical documentation (protocols, reports, specifications, regulatory submission content) for temperature-controlled packaging systems
Serve as a subject matter expert (SME) for cold chain packaging, and guide cross-functional teams on best practices
Drive resolution of packaging-related deviations and investigations, particularly those involving temperature excursions or container failures
Monitor industry trends and regulatory changes related to cold chain packaging, including sustainability innovations, digital temperature monitoring, and evolving standards (e.g., USP, ISO, ISTA)
Evaluate internal procedures and update as necessary for continuous improvement, efficiency, and compliance

Qualification

Cold chain packagingThermal performanceMaterial compatibilityRisk mitigation strategiesFDA guidelinesEMA guidelinesICH guidelinesCGMP standardsInfluencing skillsCollaborationTechnical documentationTeam leadership

Required

Minimum 8 years of related experience with a Bachelor of Science Degree in packaging, mechanical, industrial, or biomedical engineering
Minimum 6 years of related experience with a Masters of Science Degree in packaging, mechanical, industrial, or biomedical engineering
Deep technical expertise in biologics cold chain packaging, including thermal performance, material compatibility, and risk mitigation strategies
Experience with temperature-controlled shipping container qualification and the corresponding product quality testing
Strong understanding of FDA, EMA, and ICH guidelines and cGMP standards related to biologics and pharmaceutical packaging
Proven ability to collaborate with and influence external partners to deliver compliant and scalable solutions
Lead the design and qualification of thermal protection systems, collaborating with internal stakeholders (e.g., Quality, Regulatory, Supply Chain, Analytical Ops.) and external partners to ensure robust, compliant solutions
Execute simulated and real-time shipping qualifications and thermal mapping studies, ensuring compliance with global regulatory expectations
Author technical documentation (protocols, reports, specifications, regulatory submission content) for temperature-controlled packaging systems
Serve as a subject matter expert (SME) for cold chain packaging, and guide cross-functional teams on best practices
Drive resolution of packaging-related deviations and investigations, particularly those involving temperature excursions or container failures
Monitor industry trends and regulatory changes related to cold chain packaging, including sustainability innovations, digital temperature monitoring, and evolving standards (e.g., USP, ISO, ISTA)
Evaluate internal procedures and update as necessary for continuous improvement, efficiency, and compliance

Benefits

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Company

Gilead Sciences

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Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.

H1B Sponsorship

Gilead Sciences 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 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)

Funding

Current Stage
Public Company
Total Funding
$4.41B
Key Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B

Leadership Team

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Keeley Wettan
Senior Vice President, Legal
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Patrick Loerch
Senior Vice President, Clinical Data Science
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Company data provided by crunchbase