Packaging Engineer II

The Packaging Engineer II will serve as a technical contributor within the Package Development team, supporting the design, development, qualification, and implementation of primary, secondary, and tertiary packaging systems for Gilead’s pharmaceutical, biologics, and combination product pipeline. This role requires close collaboration with cross-functional teams including Product Development, Regulatory Affairs, Quality Assurance, Contract Manufacturing Organizations (CMOs), and external suppliers to ensure packaging solutions meet product, patient, and regulatory requirements across all phases of clinical development. This position is on-site, located in Foster City, California.

Key Responsibilities

• Lead packaging development activities for clinical programs, ensuring alignment with product requirements, regulatory expectations, and global standards.
• Apply sound engineering principles and industry standards (e.g., USP, ISO, ASTM) to the design and qualification of container closure systems (CCS).
• Author and execute packaging studies, including protocols and reports for component qualification, shipping validation, and compatibility assessments.
• Conduct and support equipment and process qualification activities (IQ/OQ/PQ) for packaging lines and configurations at internal and external manufacturing sites.
• Ensure packaging components and systems comply with current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines.
• Investigate and resolve packaging-related deviations, non-conformances, and complaints in collaboration with Quality and Operations teams.
• Support regulatory submissions by authoring and reviewing relevant sections of INDs, NDAs, BLAs, and other global filings.
• Maintain and author SOPs related to packaging development and ensure alignment with broader organizational procedures.
• Train new team members on packaging-related SOPs, documentation systems, and best practices.
• Collaborate with external partners including CMOs, suppliers, and test laboratories to ensure timely and compliant execution of packaging activities.
• Travel up to 20% may be required to support project execution at external sites.

Basic Qualifications

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related scientific discipline.
• At least 4 years of relevant experience in pharmaceutical, biotechnology, or medical device packaging development. Advanced degrees with commensurate experience will be considered.
• Demonstrated experience in packaging component characterization, qualification, and regulatory documentation.
• Strong working knowledge of cGMP, FDA, EMA, and ICH guidelines as they pertain to packaging systems.
• Proficiency in applying industry standards such as ASTM D4169, ISO 11607, and others relevant to packaging and CCS.
• Excellent written and verbal communication skills, with the ability to clearly document technical work and communicate across functions.
• Strong organizational and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
• Experience working with external suppliers, CMOs, and contract laboratories is highly desirable.