Location:  Florida

Summary:

The primary responsibility of this position is to work jointly with Manufacturing and Global Packaging and apply manufacturing equipment knowledge to optimize component design, product integrity and achieve sustained high efficiencies with production equipment. Other responsibilities include providing work direction of labeling graphics personnel to assure product compliance and applying project management skills to implement manufacturing type capital projects. 

Duties:

Primary responsibility for creating and maintaining all site master component specifications. Work with R&D, Regulatory Affairs, Procurement, Marketing, Global Packaging, Engineering, and suppliers to support cost, quality, and new product opportunities related to product packaging. Propose and implement creative solutions to packaging design and problem resolution. Perform problem analysis and provide resolution to packaging non-conformances. Responsible for assuring departmental component and graphics SOP’s are compliant.  Also responsible for development of equipment specifications or user requirement specifications, and analysis/selection of packaging equipment.

Primary responsibility to provide direction related to package labeling through on-site and global graphics technicians to assure product compliance and branding strategies. Review and approve graphics changes to assure they are compliant and in accordance with equipment capability.

Review filling and packaging BOM’s and manufacturing instructions to assure right first time compliance with intended package structure and equipment capability.

Apply project management skills, component design techniques, and equipment knowledge to manage capital projects. Develop and execute line engineering studies leading to validation for project implementation.  Responsible for identification and implementation of cost improvement projects in the manufacturing areas.

Education:

Minimum Bachelor’s Degree in Packaging Engineering or Mechanical Engineering with strong package engineering experience.

Experience:

Minimum 8 years experience related to packaging components, and packaging equipment in a pharmaceutical/FDA regulated facility.

Special Skills:

Prior experience with sterile processing component configurations including glass and plastic bottles, metal and polyfoil tubes, and prefilled syringes. Equipment capability experience with high speed filling, capping, labeling, banding, cartoning, bundling, and electronic verification systems.  Prior experience with managing capital projects to apply new technologies to the manufacturing operation. Must have the ability to work quickly under pressure, good paperwork skills and have attention to quality and detail. Prior Lean and 6-Sigma experience preferred.  A self starter; one that requires minimal daily direction. Excellent communication skills, both verbal and written.

Specialized Training:

Cape Pack, MRP systems, aseptic gowning certification.