Packaging Engineer

Job Title: Cold Chain Packaging Engineer (1-Year Contract)

Location: Foster City, CA (Hybrid)
Duration: 12-Month Contract
Schedule: Hybrid (Onsite/Remote)

Job Overview

We are seeking an experienced Cold Chain Packaging Engineer to join a leading biotechnology company on a 12-month contract. In this role, you will support the Packaging Development team by designing, qualifying, and managing temperature-controlled (cold chain) packaging systems that ensure product quality and regulatory compliance throughout the global distribution of pharmaceutical and biologic products.

The ideal candidate will have strong experience in cold chain packaging, thermal qualification, shipping validation, and pharmaceutical packaging development, along with excellent technical writing and problem-solving skills.

Key Responsibilities

• Develop, qualify, and maintain temperature-controlled (cold chain) packaging systems.
• Design and execute shipping qualification and thermal validation protocols.
• Author packaging protocols, qualification reports, technical documentation, and regulatory support documents.
• Develop specifications for thermal packaging components and shipping systems.
• Analyze temperature monitoring/data logger results to support qualification activities.
• Investigate packaging deviations and perform root cause analyses.
• Author, review, and update SOPs related to shipping qualification and packaging activities.
• Collaborate with cross-functional teams, packaging suppliers, and external testing laboratories.
• Ensure compliance with Good Distribution Practices (GDP) and applicable industry regulations.
• Support packaging lifecycle management and continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, or a related scientific discipline.
• 5+ years of experience in packaging engineering within the pharmaceutical or biotechnology industry.
• Hands-on experience with cold chain or temperature-controlled packaging systems.
• Experience qualifying insulated shipping containers and thermal protection systems.
• Strong knowledge of shipping qualification, thermal validation, and packaging protocols.
• Experience analyzing temperature monitoring/data logger data.
• Familiarity with Good Distribution Practices (GDP).
• Excellent technical writing, documentation, communication, and organizational skills.

Preferred Qualifications

• Experience supporting biologics or cell and gene therapy products.
• Knowledge of ISTA and ASTM shipping qualification standards.
• Experience working with external packaging vendors and contract testing laboratories.
• Experience with deviation investigations, CAPA, and root cause analysis.

Preferred Skills

• Cold Chain Packaging
• Thermal Packaging Systems
• Shipping Qualification
• Packaging Validation
• Temperature Monitoring
• GDP Compliance
• Technical Writing
• SOP Development
• Packaging Specifications
• Root Cause Analysis
• Pharmaceutical Packaging
• Biologics
• ISTA / ASTM Standards

If you have a strong background in pharmaceutical packaging development and cold chain qualification and are looking to contribute to innovative therapies in a collaborative environment, we encourage you to apply.