The Catalyst Group www.catgroupinc.com working with a 7 Billion/year, 11,000 person medical device company located in the Atlanta Georgia area. They have engaged our services to identify a Packaging Test Manager that will have responsibilities for all package testing and eventual development for this organization. The manager will work with packaging suppliers and potential new packaging and while taking ownership of material qualification, closure integrity and adherence regulations set by the FDA, ISO etc. This role will also be critical in development and implementation of Standard Operating Procedures for design development, material selection, and design control while directing the evaluation, development and implementation of global packaging systems. The packaging invovled will include primary, secondary container closures, including labeling inks/adhesives, specifications. This role will administer the packaging development lab by way of capability enhancement, staff development, allocation of resources, planning and budgeting while working with Marketing, Regulatory Affairs, Quality Assurance, Operations and Clinical Affairs.

REQUIREDBS Package Engineering. Full packaging development from package and materials selection, through criteria evaluation, validation, and implementation. Working knowledge of Design Of Experiments (DOE) and Failure Modes and Effect Analysis (FMEA) analytical tool. Packaging automation and manufacturing to include FFS, plastic molding, and assembly processes such as RF and heat welding. Experience in container closure systems as well as related filing systems for sterile and aseptic processes. Understanding of GMP, ISO, FDA, ISTA, ASTM and other regulatory issues relating to medical device packaging

Our client offers an outstanding career path, relocation, great benefits and dedicated culture focused on one thing-growth. They have recently obtained double digit growth (09 aside) and are on task to continue this.

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner

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