Packaging Engineer III

Gilead Sciences•Foster City, CA

18h

About The Position

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.

Requirements

Practical working knowledge of pharmaceutical packaging development, including container-closure systems and distribution packaging.
Experience supporting OSD packaging systems, such as bottles and blisters, including moisture‑ and light‑sensitive products.
Working familiarity with packaging requirements for biologics and drug‑device combination products, including container closure integrity and product protection considerations.
Ability to execute component characterization, qualification, and packaging studies, including shipping and distribution qualifications.
Understanding of cGMP principles and global regulatory expectations applicable to pharmaceutical packaging.
Familiarity with applicable industry standards and test methods (e.g., USP, ISO, ASTM).
Ability to author and review technical documentation using established templates and guidance.
Effective collaboration skills for working in cross‑functional and matrixed environments, including interaction with CMOs, suppliers, and contract test laboratories.
Strong organizational and time‑management skills, with the ability to manage multiple assignments and meet project timelines.
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 scientific field and a minimum of 5 years of relevant industry experience.
OR Master's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, or a related scientific field and a minimum of years of relevant industry experience.
Advanced degree(s) with commensurate industry experience will be considered.
Prior experience in a cGMP‑regulated pharmaceutical or biotechnology industry is highly desirable.

Responsibilities

Execute packaging development activities supporting product development and clinical study supplies across OSD, biologics, and combination products.
Apply pharmaceutical packaging principles to support the development, characterization, and qualification of primary, secondary, and tertiary packaging systems, including container closure and distribution packaging.
Support packaging activities through regulatory submission, ensuring documentation and data meet internal quality standards and global regulatory expectations.
Perform component characterization and qualification for packaging materials and components, including bottles, blisters, sachets, cartons, labels, and shipping systems.
Execute and document shipping qualification activities supporting development and regulatory filings, including biologics shipping data, bulk and britestock shipments, finished goods distribution for OSD products, parenteral products, and combination products.
Support execution and documentation of packaging equipment and process qualification activities (IQ/OQ/PQ) in collaboration with internal manufacturing teams and CMOs.
Provide technical support to packaging and clinical supply operations, including participation in deviation investigations, change controls, and issue resolution.
Collaborate cross‑functionally with internal teams, CMOs, suppliers, and contract test laboratories to support packaging deliverables.
Author and review technical documentation, including protocols, reports, and regulatory‑supporting content, using established templates and procedures.
Ensure assigned work is completed on time and in compliance with cGMP, GDP, and applicable regulatory and quality system requirements.
Contribute to knowledge sharing, onboarding, and continuous improvement efforts within the packaging development organization.