Packaging Engineer III

Gilead Sciences • Foster City, CA

18d • $117,895 - $152,570

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, labeling, and logistics activities, resolves quality and supply issues, and serves as a technical contact for contract packaging organizations and component suppliers.

The position collaborates with Technical Development on packaging manufacturability, scalability, and design for oral solid dose products, parenteral products, biologics, and combination products. It leads or supports packaging technology transfers and process validation across global manufacturing networks, and partners with Supply Chain, Quality, Manufacturing, and external organizations to maintain supply and support product lifecycle management.

The engineer reviews packaging component specifications, creates and maintains Bills of Materials and packaging process instructions, and initiates quality-system change controls, deviations, and CAPAs as needed. The role also supports regulatory submissions, inspections, and audits, while ensuring adherence to cGMP, regulatory, and internal quality requirements. 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.
• Strong organizational and time-management skills, with the ability to manage multiple assignments and meet project timelines.
• Good verbal, written, and interpersonal communication skills.
• Overnight travel may be required up to 20% of the time.

Nice To Haves

• Experience with package development for pharmaceutical products such as oral solid dose and parenteral products, including small molecules or biologics.
• Familiarity with applicable industry standards and test methods, such as USP, ISO, and ASTM.
• 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 issue resolution to support product quality, regulatory compliance, and continuity of supply; review deviations and CAPAs from external packaging sites.
• Serve as the primary technical point of contact for external contract packaging organizations and packaging component suppliers.
• Collaborate with Technical Development on manufacturability, scalability, and packaging design for oral solid dose products, parenteral products, biologics, and combination products.
• Lead or support packaging technology transfers from development to commercial manufacturing.
• Participate in or lead packaging process validation 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 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.
• 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 activities as needed.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

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