Gilead Sciences · 18 hours ago
Packaging Engineer II
San Francisco Bay Area
Full-time
Onsite
Mid Level
$102K/yr - $132K/yr
4+ years expGilead Sciences is a company dedicated to creating a healthier world by tackling diseases such as HIV and cancer. The Packaging Engineer II will lead packaging development activities for clinical programs, ensuring compliance with regulatory standards and overseeing the qualification of container closure systems.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
Preferred
Experience working with external suppliers, CMOs, and contract laboratories is highly desirable
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-13
Company data provided by crunchbase