Sr. 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.
** Key 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.
* 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.
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