Packaging Engineer II
Gilead Sciences
August 31, 2026
On-site
San Francisco Bay Area
Operations
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 on manufacturability, scalability, and packaging design for oral solid dose, parenteral, biologics, and combination products.
- Lead/support technology transfer for packaging processes from development to commercial manufacturing.
- Participate in/lead packaging process validation for oral solid dose and parenteral products across global manufacturing networks.
Cross-Functional Partnership & Supply Continuity
- Partner with Supply Chain, Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply.
- Represent Packaging & Labeling on CMC teams; support lifecycle management.
- Support leadership with resource planning and financial reporting.
Packaging Development & Documentation
- Review/approve specifications for primary, secondary, and tertiary packaging components.
- Author/maintain Bills of Materials (BOMs) and packaging process instructions.
- Initiate change controls, deviations, and CAPAs in the Quality Management system.
Compliance & Regulatory Oversight
- Ensure compliance with cGMP and applicable regulatory/internal quality requirements for global pharmaceutical packaging operations.
- Support regulatory submissions, agency inspections, and quality audits as needed.
Basic Qualifications
- Bachelor’s degree in a relevant field with 4+ years of relevant industry experience.
- OR Master’s degree with 2+ years of relevant industry experience.
Required/Preferred Skills
- Experience with shipping qualifications/transportation studies (protocol, sampling, reports).
- Experience creating material specifications, BOMs, packaging instructions, and SOPs.
- Familiarity with cGMP, pharmaceutical manufacturing principles, global packaging standards; USP/ISO/ASTM.
- Knowledge of distribution/cold chain requirements; serialization (DSCSA, EU FMD) is a plus.
- Strong organizational/time management and communication; manage multiple assignments; travel up to 20%.
Benefits/Compensation
- Salary range: $102,085.00–$132,110.00; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and benefits (medical/dental/vision/life insurance).
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday (for current Gilead employees and contractors).
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 on manufacturability, scalability, and packaging design for oral solid dose, parenteral, biologics, and combination products.
- Lead/support technology transfer for packaging processes from development to commercial manufacturing.
- Participate in/lead packaging process validation for oral solid dose and parenteral products across global manufacturing networks.
Cross-Functional Partnership & Supply Continuity
- Partner with Supply Chain, Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply.
- Represent Packaging & Labeling on CMC teams; support lifecycle management.
- Support leadership with resource planning and financial reporting.
Packaging Development & Documentation
- Review/approve specifications for primary, secondary, and tertiary packaging components.
- Author/maintain Bills of Materials (BOMs) and packaging process instructions.
- Initiate change controls, deviations, and CAPAs in the Quality Management system.
Compliance & Regulatory Oversight
- Ensure compliance with cGMP and applicable regulatory/internal quality requirements for global pharmaceutical packaging operations.
- Support regulatory submissions, agency inspections, and quality audits as needed.
Basic Qualifications
- Bachelor’s degree in a relevant field with 4+ years of relevant industry experience.
- OR Master’s degree with 2+ years of relevant industry experience.
Required/Preferred Skills
- Experience with shipping qualifications/transportation studies (protocol, sampling, reports).
- Experience creating material specifications, BOMs, packaging instructions, and SOPs.
- Familiarity with cGMP, pharmaceutical manufacturing principles, global packaging standards; USP/ISO/ASTM.
- Knowledge of distribution/cold chain requirements; serialization (DSCSA, EU FMD) is a plus.
- Strong organizational/time management and communication; manage multiple assignments; travel up to 20%.
Benefits/Compensation
- Salary range: $102,085.00–$132,110.00; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and benefits (medical/dental/vision/life insurance).
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday (for current Gilead employees and contractors).