Packaging Engineer III

Gilead Sciences • Foster City, CA

17d

About The Position

Gilead is seeking a Packaging Engineer III to provide technical support for commercial pharmaceutical packaging operations and external manufacturing partners. The role supports packaging and labeling quality, regulatory compliance, and continuity of supply across global manufacturing networks. It works with products including oral solid dose, parenteral, biologic, and combination products.

The engineer collaborates with Technical Development on manufacturability, scalability, and packaging design; leads or supports technology transfers and packaging process validation; and partners with Supply Chain, Quality, Manufacturing, and external organizations. The position also supports product lifecycle management, department resource planning and financial reporting, packaging documentation, regulatory submissions, inspections, and audits. Overnight travel may be required up to 20% of the time.

Requirements

• Bachelor’s degree in Packaging Engineering, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related technical field and at least 5 years of relevant industry experience; or a master’s degree in a related field and at least 3 years of relevant industry experience.
• Experience performing shipping qualifications and transportation studies, including protocol authoring, sample preparation, and report authoring.
• Experience creating material specifications for primary, secondary, and tertiary packaging materials and components, Bills of Materials, packaging instructions, and Standard Operating Procedures.
• Experience working with packaging sites and external contract packaging organizations to support routine production.
• Experience supporting new product introductions, technology transfers, and commercial launches in major global markets.
• Understanding of cGMPs, pharmaceutical manufacturing principles, and global packaging standards.
• Familiarity with applicable industry standards and test methods, such as USP, ISO, and ASTM.
• Strong organizational and time-management skills, including the ability to manage multiple assignments and meet project timelines.
• Good verbal, written, and interpersonal communication skills.

Nice To Haves

• Experience with package development for pharmaceutical products such as oral solid dose and parenteral products, including small molecules or biologics.
• Knowledge of distribution and cold-chain shipping requirements for oral solid dose and parenteral products.
• Familiarity with pharmaceutical serialization requirements, including DSCSA and the EU Falsified Medicines Directive (FMD).

Responsibilities

• Provide technical support for routine commercial packaging operations at external Contract Manufacturing Organizations (CMOs), including management of packaging, labeling, and logistics deviations, complaints, and investigations.
• Drive timely resolution of issues to support product quality, regulatory compliance, and continuity of supply.
• Review deviations and CAPAs from external packaging sites.
• Serve as the primary technical contact for external contract packaging organizations and packaging component suppliers.
• Collaborate with Technical Development on manufacturability, scalability, and packaging design for oral solid dose, parenteral, biologic, and combination products.
• Lead or support packaging process technology transfers from development to commercial manufacturing.
• Participate in or lead packaging process validation activities for oral solid dose and parenteral products across global manufacturing networks.
• Partner with Supply Chain, Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply.
• Represent Packaging & Labeling on CMC teams and support product lifecycle management activities.
• Support department leadership with resource planning and financial reporting.
• Review and approve specifications for primary, secondary, and tertiary commercial packaging components.
• Author and maintain Bills of Materials (BOMs) and packaging process instructions for new and existing products.
• Initiate change controls, deviations, and CAPAs in Gilead’s Quality Management system when required.
• Maintain awareness of and ensure compliance with cGMP, regulatory, and internal quality requirements for global pharmaceutical packaging operations.
• Support regulatory submissions, regulatory agency inspections, and quality audits related to packaging and labeling as needed.
• Perform shipping qualifications and transportation studies, including protocol authoring, sample preparation, and report authoring.
• Travel overnight as required, potentially up to 20% of the time.

Benefits

• Discretionary annual bonus eligibility.
• Discretionary stock-based long-term incentive eligibility, which may vary by role.
• Paid time off.
• Company-sponsored medical, dental, vision, and life insurance plans.
• A benefits package, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level