Sr. Packaging Engineer II - Cold Chain

Gilead Sciences, Inc.•Foster City, CA

35d•Onsite

About The Position

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Senior Packaging Engineer II - Cold Chain This position resides on the Package Development team at Gilead, where we create packaging solutions for our pharmaceutical and biologics pipeline. This role is focused on the development, qualification, and lifecycle management of temperature-controlled packaging systems for biologics and small molecules, ensuring product integrity and compliance throughout global distribution. This is an on-site position located in Foster City, California.

Requirements

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.
Proven ability to collaborate with and influence external partners to deliver compliant and scalable solutions.
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.

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.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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