Sr. Packaging Engineer II - Cold Chain

Role Summary

As a Senior Packaging Engineer at Gilead, you will lead 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 role located in Foster City, California. You will act as a subject matter expert for cold chain packaging, guiding cross-functional teams and external partners to deliver compliant and scalable solutions.

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.

Qualifications

• Required: Deep technical expertise in biologics cold chain packaging, including thermal performance, material compatibility, and risk mitigation strategies.
• Required: Experience with temperature-controlled shipping container qualification and the corresponding product quality testing.
• Required: Strong understanding of FDA, EMA, and ICH guidelines and cGMP standards related to biologics and pharmaceutical packaging.
• Required: Proven ability to collaborate with and influence external partners to deliver compliant and scalable solutions.
• Preferred: Experience influencing cross-functional teams and external partners to deliver high-quality, compliant packaging solutions.

Skills

• Subject matter expert for cold chain packaging with the ability to translate regulatory expectations into practical packaging solutions.
• Strong communication and collaboration skills to work with Quality, Regulatory, Supply Chain, Analytical Ops, and external partners.

Education

• 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 Master of Science Degree in packaging, mechanical, industrial, or biomedical engineering.