· 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 *** 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
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”