Sr. Packaging Engineer II - Cold Chain
Listed on 2025-12-12
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Engineering
Packaging Engineer, Quality Engineering
At Gilead, we’re creating a healthier world for all people. Over the past 35 years, we tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – relentlessly developing therapies that improve lives and ensuring global access to these treatments. We continue to fight the world’s biggest health challenges with 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, and we’re looking for passionate and ambitious people ready to make a direct impact.
Job Description Senior Packaging Engineer II – Cold ChainThis position resides on the Package Development team at Gilead, where we create packaging solutions for our pharmaceutical and biologics pipeline. The role focuses 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.
The salary range for this position is: $ - $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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*.
For Additional Benefits Information, Visit
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made…
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