Packaging Engineer III
Gilead Sciences
June 26, 2026
On-site
San Francisco Bay Area
Operations
Key Responsibilities:
- Execute packaging development for product development and clinical study supplies across oral solid dose (OSD), biologics, and drug-device combination products.
- Apply pharmaceutical packaging principles to develop, characterize, and qualify primary/secondary/tertiary packaging (container-closure and distribution packaging).
- Support packaging regulatory submissions; ensure documentation meets quality and global regulatory expectations.
- Perform component characterization/qualification (e.g., bottles, blisters, sachets, cartons, labels, shipping systems).
- Execute/document shipping qualification (biologics shipping data; bulk/britestock; finished goods distribution for OSD/parenteral/combination products).
- Support packaging equipment/process qualification (IQ/OQ/PQ) with internal manufacturing teams and CMOs.
- Provide technical support to packaging/clinical supply operations (deviations, change controls, issue resolution).
- Author/review technical documentation (protocols, reports, regulatory-supporting content).
- Ensure on-time delivery in compliance with cGMP/GDP and applicable requirements.
- Contribute to knowledge sharing, onboarding, and continuous improvement.
Knowledge/Skills/Abilities:
- Working knowledge of pharmaceutical packaging development; container-closure and distribution packaging.
- Experience with OSD packaging (incl. moisture/light-sensitive products).
- Familiarity with biologics and drug-device combination packaging requirements.
- Ability to execute qualification studies (incl. shipping/distribution).
- Understanding of cGMP; familiarity with USP/ISO/ASTM; ability to author/review technical docs; strong collaboration, communication, organization.
- Overnight travel up to 20%.
Basic Qualifications:
- Bachelor’s degree in a relevant engineering/scientific field + minimum 5 years relevant industry experience.
OR Master’s degree in relevant field + minimum years relevant industry experience; advanced degrees with commensurate experience considered. cGMP-regulated pharma/biotech experience highly desirable.
Benefits/Pay (as stated): $117,895.00–$152,570.00; may include discretionary bonus/stock incentives; paid time off; company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- For current Gilead employees and contractors: Apply via the Internal Career Opportunities portal in Workday.
- Execute packaging development for product development and clinical study supplies across oral solid dose (OSD), biologics, and drug-device combination products.
- Apply pharmaceutical packaging principles to develop, characterize, and qualify primary/secondary/tertiary packaging (container-closure and distribution packaging).
- Support packaging regulatory submissions; ensure documentation meets quality and global regulatory expectations.
- Perform component characterization/qualification (e.g., bottles, blisters, sachets, cartons, labels, shipping systems).
- Execute/document shipping qualification (biologics shipping data; bulk/britestock; finished goods distribution for OSD/parenteral/combination products).
- Support packaging equipment/process qualification (IQ/OQ/PQ) with internal manufacturing teams and CMOs.
- Provide technical support to packaging/clinical supply operations (deviations, change controls, issue resolution).
- Author/review technical documentation (protocols, reports, regulatory-supporting content).
- Ensure on-time delivery in compliance with cGMP/GDP and applicable requirements.
- Contribute to knowledge sharing, onboarding, and continuous improvement.
Knowledge/Skills/Abilities:
- Working knowledge of pharmaceutical packaging development; container-closure and distribution packaging.
- Experience with OSD packaging (incl. moisture/light-sensitive products).
- Familiarity with biologics and drug-device combination packaging requirements.
- Ability to execute qualification studies (incl. shipping/distribution).
- Understanding of cGMP; familiarity with USP/ISO/ASTM; ability to author/review technical docs; strong collaboration, communication, organization.
- Overnight travel up to 20%.
Basic Qualifications:
- Bachelor’s degree in a relevant engineering/scientific field + minimum 5 years relevant industry experience.
OR Master’s degree in relevant field + minimum years relevant industry experience; advanced degrees with commensurate experience considered. cGMP-regulated pharma/biotech experience highly desirable.
Benefits/Pay (as stated): $117,895.00–$152,570.00; may include discretionary bonus/stock incentives; paid time off; company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- For current Gilead employees and contractors: Apply via the Internal Career Opportunities portal in Workday.