Biomedical Engineering, Biotech and Pharmaceutical, Chemical Engineering, Communication Skills, Data Analysis, Industrial Engineering, Mechanical Engineering, Organizational Skills, Regulations, Regulatory Compliance, Regulatory Submissions, Requirements Management, Root Cause Analysis, Standard Operating Procedures (SOP), Technical Support, Technical Writing, Test Lab, Willing to Travel, Writing Skills
Location: Foster City, CA (Hybrid)
Pay: $88.89 - $96.29
This position resides within the Packaging Development team at Client, with a primary focus on the development, qualification, and lifecycle management of controlled temperature (cold chain) packaging systems (thermal protection systems) to ensure product quality and regulatory compliance across global distribution of our pharmaceuticals and biologics products.
Specific Job Requirements- Author packaging protocols, reports, and technical documentation to support shipping qualification and regulatory filings
- Design and execute qualification plans for thermal protection systems
- Develop specifications for thermal protection systems components
- Support deviation investigations and root cause assessments, as required
- · Download and analyze temperature monitoring data to support thermal qualification activities
- Author and review SOPs related to shipping qualification activities ensuring alignment with other Client quality systems and procedures
- Potential for travel up to 10%.
Knowledge- Strong technical skills and knowledge of package development and cold chain principals
- Working knowledge of temperature-controlled shipping container qualification standards and regulations
- Understanding of Good Distribution Practices
- Strong communication, technical writing, and organizational skills
- Experience collaborating with external suppliers and/or contract test laboratories is desirable
Specific Education and Experience- B.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field. Advanced degree(s) with commensurate industry experience considered.
- Experience in the biotechnology or pharmaceutical industry preferred - 5+ years of hands-on experience
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Integrated Resources, Inc