Sr. Packaging Engineer I

Gilead Sciences • Foster City, CA

9d • Onsite

About The Position

At Gilead, we are 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, development and supply 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. This position is in the Gilead External Manufacturing group, which is part of Gilead Manufacturing Operations organization. This role is based at Gilead’s Foster City, California, location

Requirements

• Bachelor’s degree in Packaging Engineering, Biomedical Engineering, Mechanical Engineering, Industrial Engineering , or a related technical field with at least 8 years of relevant industry experience, OR Master’s degree in a related field with at least 6 years of relevant industry experience.
• Strong knowledge of cGMPs , pharmaceutical manufacturing principles, and global packaging standards.
• Technical proficiency, independent thinking, teamwork and collaboration, including driving continuous improvement.
• Demonstrated experience with secondary and tertiary packaging for parenteral products (small molecules and biologics).
• Experience supporting new product introductions, technology transfers, and commercial launches in major global markets.
• Proven experience working with and managing external contract packaging organizations .
• Experience managing complex, cross‑functional projects across multiple regions and time zones.
• Financial acumen related to budgeting, forecasting, and cost optimization .
• Working knowledge of statistical methods and software to support packaging process optimization and troubleshooting.

Nice To Haves

• Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD) (preferred).
• Knowledge of distribution and cold chain shipping requirements for parenteral products; experience with shipping qualifications and transportation studies is a plus.

Responsibilities

• Provide technical support for routine commercial packaging operations at external Contract Manufacturing Organizations (CMOs), including management of deviations, complaints, and investigations related to packaging, labeling, and logistics.
• Drive timely issue resolution to ensure product quality, regulatory compliance, and continuity of supply.
• Serve as the primary technical point of contact for external contract packaging organizations and packaging component suppliers.
• Partner closely with Supply Chain, Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply.
• Represent Packaging & Labeling on CMC teams , supporting lifecycle management activities for Gilead products.
• Support department leadership with resource planning and financial reporting activities.
• Review and approve specifications for primary, secondary, and tertiary packaging components used for commercial products.
• Author and maintain Bills of Materials (BOMs) and packaging process instructions for new and existing products.
• Collaborate with Technical Development to provide input on manufacturability, scalability, and packaging design for parenteral finished goods , including small molecules, biologics, and combination products .
• Lead or support technology transfer activities for packaging processes from development to commercial manufacturing.
• Participate in or lead packaging process validation activities for parenteral products across global manufacturing networks.
• Maintain awareness of and ensure compliance with cGMP , regulatory, and internal quality requirements applicable to global pharmaceutical packaging operations.
• Support regulatory submissions, inspections, and responses related to packaging and labeling activities, as needed.

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: Mid Level