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 Support 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. Review deviations and CAPAs from external packaging site Serve as the primary technical point of contact for external contract packaging organizations and packaging component suppliers. Technology Transfer & Validation Collaborate 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 Continuity 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. Packaging Development & Documentation 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 Quality Management system when required. Compliance & Regulatory Oversight Maintain 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 Qualifications Bachelor’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, OR Master’s degree in a related field with minimum of 2 years of relevant industry experience. Knowledge, Experience And Skills Experience 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 communication skills are required. Overnight travel may be required up to 20% of the time. The salary range for this position is: $102,085.00 - $132,110.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.