Sr Packaging Engineer I

Gilead Sciences • Foster City, CA

3d

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Senior Packaging Engineer I is a senior individual contributor within the Package Development organization, responsible for leading packaging development activities supporting product development and clinical study supplies across oral solid dose (OSD), biologics, and drug‑device combi nation products. This role provides technical leadership for the development, qualification, and support of primary, secondary, and tertiary packaging systems, partnering cross‑functionally with Product Development, Clinical Supply, Quality, Regulatory Affairs, Manufacturing, Supply Chain, External Manufacturing (CMOs), and suppliers. The Senior Packaging Engineer I is accountable for packaging activities through regulatory submission and plays a key role in commercial readiness, ensuring packaging systems and qualification strategies support a successful transition to commercial operations. The role operates with a high degree of independence, mentors less‑experienced engineers, and leads resolution of complex packaging challenges while ensuring compliance, quality, and timely delivery.

Requirements

• Bachelor's Degree and 6 years’ experience OR Master's Degree and 4 years’ experience OR PhD /PharmD

Nice To Haves

• Strong technical expertise in pharmaceutical packaging development, including container closure systems and distribution packaging.
• Experience supporting packaging systems for OSD products (e.g., bottles, blisters), biologics, and combination products.
• Solid understanding of cGMP and global regulatory expectations for pharmaceutical packaging.
• Proven ability to collaborate effectively with cross‑functional teams, CMOs, suppliers, and contract test laboratories.
• Strong written and verbal communication skills and sound engineering judgment.
• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, or a related field, with 6+ years of relevant industry experience.
• Advanced degree (M.S. or Ph.D.) with commensurate experience.
• Experience in a cGMP‑regulated pharmaceutical or biotechnology environment.
• Familiarity with USP, ASTM, ISTA, and TAPPI standards.
• Experience with shipping qualification, including biologics and temperature‑controlled systems.
• Experience using electronic quality and documentation systems (e.g., Veeva).
• Exposure to sustainable packaging initiatives is a plus.

Responsibilities

• Lead packaging development activities for OSD, biologics, and drug‑device combination products.
• Provide technical leadership on assigned programs, including defining packaging approaches and identifying technical and supply risks.
• Lead the development, characterization, and qualification of primary, secondary, and tertiary packaging systems, including container closure and distribution packaging.
• Support commercial readiness for later‑phase products by ensuring packaging systems, specifications, and qualification strategies are scalable and aligned with commercial manufacturing and distribution requirements.
• Drive packaging activities through regulatory submission, ensuring studies and documentation are complete and submission‑ready.
• Lead material selection, component characterization, and qualification for packaging components such as bottles, blisters, sachets, cartons, labels, and shipping systems.
• Own and execute shipping qualification activities, including biologics, bulk and britestock shipments, finished goods distribution for OSD products, and temperature‑controlled shipping systems (e.g., ISTA 7D), as applicable.
• Lead execution and documentation of packaging equipment and process qualification/validation activities (IQ/OQ/PQ) in collaboration with internal manufacturing teams and CMOs.
• Partner with Commercial Packaging Engineering, Manufacturing, and Supply Chain to support technical handoffs and launch readiness.
• Lead or support deviation investigations, change controls, and issue resolution in collaboration with Quality and Operations.
• Author and review technical and regulatory documentation, including protocols, reports, SOPs, and filing‑supporting content.
• Mentor junior packaging engineers and support onboarding and training activities.
• Identify opportunities for continuous improvement and standardization within packaging development.
• Overnight travel up to 20–25% may be required.

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
• Number of Employees: 5,001-10,000 employees