Packaging Engineer II

Responsibilities

• Provide technical support for commercial packaging operations at external Contract Manufacturing Organizations (CMOs), managing deviations, complaints, and investigations.
• Lead or support technology transfer activities and packaging process validation for oral solid dose and parenteral products.
• Serve as the primary technical point of contact for external packaging organizations and component suppliers.
• Review and approve specifications for primary, secondary, and tertiary packaging components.
• Author and maintain Bills of Materials (BOMs), packaging instructions, and Standard Operating Procedures.
• Partner with Supply Chain, Quality, and Manufacturing teams to ensure uninterrupted commercial supply and support CMC lifecycle management.
• Ensure compliance with cGMP, regulatory requirements, and internal quality standards.

Requirements

• Bachelor’s degree in Packaging, Biomedical, Mechanical, or Industrial Engineering with 4+ years of relevant industry experience, OR a Master’s degree in a related field with 2+ years of experience.
• Experience performing shipping qualifications and transportation studies, including protocol and report authoring.
• Experience creating material specifications, Bills of Materials (BOMs), and packaging instructions.
• Knowledge of cGMP and pharmaceutical manufacturing principles.
• Familiarity with industry standards such as USP, ISO, or ASTM.
• Ability to manage multiple assignments and meet project timelines.
• Willingness to travel overnight up to 20% of the time.

Preferred Qualifications

• Experience with package development for oral solid dose or parenteral products (small molecules or biologics).
• Knowledge of distribution and cold chain shipping requirements.
• Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD).

About the Company

Gilead Sciences is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.