Packaging Engineer II

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 Packaging Engineer II, Global External Manufacturing 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.This position is in the Gilead External Manufacturing group, which is part of Gilead Manufacturing Operations organization.  This role is in the Gilead Foster City location.Key Responsibilities Commercial Packaging & External Manufacturing SupportProvide 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.  Review deviations and CAPAs from external packaging siteServe as the primary technical point of contact for external contract packaging organizations and packaging component suppliers. Technology Transfer & ValidationCollaborate with Technical Development to provide input on manufacturability, scalability, and packaging design for oral solid dose products, parenteral products, 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 oral solid dose products and parenteral products across global manufacturing networks. Cross‑Functional Partnership & Supply ContinuityPartner 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. Packaging Development & DocumentationReview 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 Quality Management system when required.Compliance & Regulatory OversightMaintain awareness of and ensure compliance with cGMP, regulatory, and internal quality requirements applicable to global pharmaceutical packaging operations.Support regulatory submissions, regulatory agency inspections, and quality audits related to packaging and labeling activities, as needed. Basic QualificationsBachelor’s degree in Packaging Engineering, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related technical field with minimum of 4 years of relevant industry experience,ORMaster’s degree in a related field with minimum of 2 years of relevant industry experience. Knowledge, Experience And SkillsExperience performing shipping qualifications and transportation studies including protocol authoring, sample preparation and report authoring. Experience creating material specifications (primary, secondary and tertiary packaging materials and components), Bill of Materials, packaging instructions, and Standard Operating Procedures.Experience with package development for for various pharmaceutical products such as oral solid dose and parenteral products (small molecules or biologics) is a plus.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 (e.g., USP, ISO, ASTM).  Knowledge of distribution and cold chain shipping requirements for oral solid dose and parenteral products is a plus.Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD) is a plus.Strong organizational and time‑management skills, with the ability to manage multiple assignments and meet project timelines.Good verbal, written, and interpersonal communicatio