Packaging Engineer in Santa Monica, CA

Knowledge:

• Good verbal, written, and interpersonal communication skills are required.
• Working knowledge and computer skills required.
• Must be able to anticipate routine client obstacles and difficulties of and act upon this in order to meet goals.
• Must be able to write clear, concise and error-free documents.
• Must be able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
• Must have knowledge of the FDA, cGMP, and GCP standards. Specific Education & Experience
• **Key Requirements: candidates: must be driven, must be motivated and willing to learn new things, ready to work hard/ try hard/ try new things; must being willing to collaborate with colleagues and help with heavy bandwidth/ work loads on others.

Responsibilities:

• The ability to work independently in a dynamic work environment managing their own projects.
• Using the resources of the team to fully immerse ones self into their projects and implement with support from the team.
• While utilizing industry best practices to conduct the design, development, qualification, and implementation of packaging and labeling materials for temperature-controlled, sterile products
• Write engineering test protocols, execute testing in conjunction with internal partners and third-party laboratories, and write engineering test summary reports
• Write material specifications and process instructions for new and existing packaging and labeling materials
• Qualify shipping methods and processes to ensure the safe delivery of life-saving therapies
• Engineer will also be responsible for Investigating complaints/deviations and develop solutions for issues related to logistics, packaging (materials and design), labeling and cold chain transport
• Provide support for lifecycle management of cold chain packaging and labeling components
• Provide packaging and shipping expertise to support both internal and external logistics and supply chain partners
• Comply with the company change control procedures to ensure that only approved packaging materials and processes are used
• Identify alternate suppliers, as appropriate
• Work closely with internal partners, Materials Management, Quality, and Manufacturing to provide packaging and labeling solutions
• Successfully operate in a fast paced and dynamic cross-functional environment
• Cold chain packaging and shipping experience desired

Education Requirements:

• Bachelor of Science Degree in Mechanical, Industrial, Chemical, Packaging Engineering, and/or a related field with a minimum of 3-5 years of related experience

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