Packaging Engineer/Process Validation Engineer - Urgent Need

Job Summary

To plan, organize, and coordinate all Packaging Engineering and labeling related activities to support:

• Development and commercialization of new products and line extensions
• Maintenance-of-business activities
• Cost Improvement Programs
• Testing and labeling activities to support ever-changing regulatory and industry requirements
• Investigation, evaluation, and implementation of new packaging concepts, materials and systems

Essential Duties and Position Responsibilities

• Support new product team and line extension activities including:
• Concept development
• Project Plans/Schedules
• Design reviews and design for manufacturability
• Develop prototype packaging/tooling
• Plan and coordinate all activities to launch and commercialize new products and line extensions including:
• Concept and development of packaging methods and processes
• Cordination of all new tooling and equipment
• Cordination of labeling
• Development and release of all new product and process documentation
• Creation of all relevant test protocols and technical reports
• Planning, ordering and coordination of all new component inventory
• Qualification and validation of all new components, equipment, processes and operations
• New product cost estimates for packaging
• Preparation of AFE(s)
• Evaluation and recommendation of new materials
• Plan and coordinate all packaging engineering activities to transfer new products and line extensions to manufacturing including:
• Development and management for packaging requirements of the transfer plan
• Development and release of all packaging documentation
• Creation of all relevant test protocols and technical reports
• Provide packaging engineering support to manufacturing including the following:
• Assessment and development of action plans to overcome packaging related manufacturing issues
• Support of cost improvement programs and manufacturing improvement plans related to product packaging
• Provide technical leadership for:
• Technical initiatives, CAPA resolutions, compliance projects

Qualifications, Knowledge, and Skills Required

• Senior Packaging Engineer: B.S. degree in Packaging Engineering/Packaging Science, Life Sciences or other Engineering discipline required, with a minimum of five (5) years in packaging engineering and design, or M.S. degree in Packaging Engineering/Packaging Science, Life Sciences or other Engineering discipline required, with a minimum of four (4) years relevant experience
• Experience in the medical device or pharmaceutical industries preferred.
• Ability to handle a variety of assignments at the same time.
• High level of written and verbal communications skills.
• Knowledge of FDA and functional requirements for sterile, non-sterile, disposable, and reusable devices.
• Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through to completion on time and on budget.
• Broad knowledge of properties for materials utilized in primary and secondary packaging, plus packaging methods and equipment.
• Working knowledge of package test methods, process validation, bar coding and international standards.
• Some travel required.