Senior Packaging Engineer II
Gilead
- Foster City, CA
- $154,020-199,320 per year
- Permanent
- Full-time
- Provide technical leadership in temperature-controlled shipping containers, collaborating with stakeholders and suppliers to design solutions and execute qualification studies.
- Establish infrastructure for shipping container solutions, ensuring alignment with stakeholder needs.
- Develop processes for controlled container qualifications and temperature-controlled shipping qualifications for biologic products.
- Author packaging protocols and reports to support product development and regulatory filings.
- Author and review global regulatory filings and respond to questions related to container closure systems.
- Communicate project goals and results across cross-functional teams.
- Lead packaging activities for multiple clinical programs, ensuring on-time delivery and cGMP compliance.
- Execute packaging equipment and process verification and validation studies to prove the effectiveness of new packaging configurations and/or packaging lines/sites.
- Support packaging operations and drive resolution of deviations and investigations promptly.
- Perform characterization and qualification of primary packaging components.
- Write and review SOPs related to packaging, ensuring alignment with other Gilead SOPs.
- Monitor industry trends and best practices for package design technologies (e.g., novel packaging configurations, sustainability) and changes in the regulatory landscape related to container closure systems, secondary package design, and controlled temperature containers.
- Lead departmental strategic initiatives.
- Participate in standards organizations (e.g., USP, ISO, ASTM, ISTA).
- Serve as SME and mentor other packaging engineers in cold chain packaging.
- Potential for overnight travel up to 25%.
- Excellent technical skills and knowledge of package development principles.
- Specific experience in the biotechnology sector is preferred.
- Detailed understanding of component and line qualification.
- Knowledge of temperature-controlled shipping container qualification (ISTA 7D).
- Understanding of FDA and cGMP standards.
- Strong communication and organizational skills.
- Experience collaborating with external suppliers, contract manufacturing organizations, or contract test laboratories desirable.
- B.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 8 years of relevant industry experience. OR
- M.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 6 years of relevant industry experience. OR
- PhD in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 0 years of relevant industry experience.
- Advanced degree(s) with commensurate industry experience considered.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.