Sr. Packaging Engineer I
Gilead Sciences
1 month ago
On-site
San Francisco Bay Area
$136,340 - $176,440 USD yearly
Operations
Key Responsibilities
- Provide technical support for routine commercial packaging operations at external CMOs, including deviations, complaints, and investigations related to packaging, labeling, and logistics.
- Drive timely issue resolution to ensure product quality, regulatory compliance, and continuity of supply.
- Serve as primary technical point of contact for external contract packaging organizations and packaging component suppliers.
- Partner with Supply Chain, Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply; represent Packaging & Labeling on CMC teams and support lifecycle management.
- Support resource planning and financial reporting.
- Review/approve packaging component specifications; author/maintain BOMs and packaging process instructions.
- Collaborate on manufacturability, scalability, and packaging design for parenteral finished goods.
- Lead/support packaging technology transfer and packaging process validation across global networks.
- Maintain compliance with cGMP/regulatory/internal quality requirements; support packaging/labeling regulatory submissions and inspections.
Basic Qualifications
- Bachelor’s degree in Packaging/ Biomedical/ Mechanical/ Industrial Engineering or related field + 8+ years relevant industry experience.
OR
- Master’s degree + 6+ years relevant industry experience.
Preferred/Required Skills & Experience
- Strong cGMP knowledge; packaging standards; experience with secondary/tertiary packaging for parenteral (small molecules/biologics).
- Experience with new product introductions, tech transfers, and commercial launches; managing external contract packaging organizations.
- Cross-functional project management across regions/time zones.
- Serialization familiarity (DSCSA and EU FMD preferred); cold chain/distribution knowledge (shipping studies a plus).
- Financial acumen; statistical methods/software for optimization/troubleshooting.
Benefits
- Company-sponsored medical, dental, vision, and life insurance; paid time off; may include discretionary annual bonus and stock-based long-term incentives.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
- Provide technical support for routine commercial packaging operations at external CMOs, including deviations, complaints, and investigations related to packaging, labeling, and logistics.
- Drive timely issue resolution to ensure product quality, regulatory compliance, and continuity of supply.
- Serve as primary technical point of contact for external contract packaging organizations and packaging component suppliers.
- Partner with Supply Chain, Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply; represent Packaging & Labeling on CMC teams and support lifecycle management.
- Support resource planning and financial reporting.
- Review/approve packaging component specifications; author/maintain BOMs and packaging process instructions.
- Collaborate on manufacturability, scalability, and packaging design for parenteral finished goods.
- Lead/support packaging technology transfer and packaging process validation across global networks.
- Maintain compliance with cGMP/regulatory/internal quality requirements; support packaging/labeling regulatory submissions and inspections.
Basic Qualifications
- Bachelor’s degree in Packaging/ Biomedical/ Mechanical/ Industrial Engineering or related field + 8+ years relevant industry experience.
OR
- Master’s degree + 6+ years relevant industry experience.
Preferred/Required Skills & Experience
- Strong cGMP knowledge; packaging standards; experience with secondary/tertiary packaging for parenteral (small molecules/biologics).
- Experience with new product introductions, tech transfers, and commercial launches; managing external contract packaging organizations.
- Cross-functional project management across regions/time zones.
- Serialization familiarity (DSCSA and EU FMD preferred); cold chain/distribution knowledge (shipping studies a plus).
- Financial acumen; statistical methods/software for optimization/troubleshooting.
Benefits
- Company-sponsored medical, dental, vision, and life insurance; paid time off; may include discretionary annual bonus and stock-based long-term incentives.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.