Packaging Engineer I

Gilead Sciences • Foster City, CA

2d

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 The Packaging Engineer I will serve as a technical contributor within the Package Development team, supporting the design, development, qualification, and implementation of primary, secondary, and tertiary packaging systems for, Gilead’s pharmaceutical, biologics, and combination product pipeline. This role requires close collaboration with cross-functional teams including Product Development, Regulatory Affairs, Quality Assurance, Contract Manufacturing Organizations (CMOs), and external suppliers to ensure packaging solutions meet product, patient and regulatory requirements across all phases of development.

Requirements

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related scientific discipline with at least 2 years of relevant experience in pharmaceutical, biotechnology, or medical device packaging development.
• Advanced degrees with commensurate experience will be considered.
• Demonstrated experience in packaging component characterization, qualification, and regulatory documentation.
• Strong working knowledge of cGMP, FDA, EMA, and ICH guidelines relevant to packaging systems.
• Proficiency in applying industry standards such as USP <1207>, ASTM D4169, ISO 11607, and other packaging- and CCS‑related standards.
• Excellent written and verbal communication skills, with the ability to clearly document technical work and collaborate across functions.
• Strong organizational and project management skills with the ability to manage multiple priorities in a fast-paced environment.

Nice To Haves

• Experience working with external suppliers, CMOs, and contract laboratories is highly desirable.

Responsibilities

• Lead packaging development activities, ensuring alignment with product requirements, regulatory expectations, and global standards.
• Apply sound engineering principles and relevant industry standards (e.g., USP, ISO, ASTM) to the design and qualification of container closure systems (CCS).
• Author and execute packaging studies, including protocols and reports for component qualification, shipping qualification, and compatibility assessments.
• Conduct and support equipment and process qualification activities for packaging lines and configurations at internal and external manufacturing sites.
• Ensure packaging components and systems comply with current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines.
• Investigate and resolve packaging-related deviations, non‑conformances, and complaints in collaboration with Quality and Operations teams.
• Support regulatory submissions by authoring and reviewing relevant sections of INDs, NDAs, BLAs, and other global filings.
• Maintain and author SOPs related to packaging development, ensuring alignment with broader organizational procedures.
• Collaborate with external partners—including CMOs, suppliers, and test laboratories—to ensure timely and compliant execution of packaging activities.

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.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees