Packaging Engineer​/Process Validation Engineer

Position: Packaging Engineer / Process Validation Engineer

Location: Warwick, RI

Duration: 6 months

Hours per week: 40.00

Shift: 1st Shift

Client: Medical Devices Company

Job Category: Engineering

Level of

Experience:

Mid-Level

Employment Type: Contract on W2 (US Citizens, GC Holders, or GC EAD/OPT/EAD/CPT)

Summary/Purpose of Position: To plan, organize, and coordinate all Packaging Engineering and labeling related activities to support:

• Development and commercialization of new products and line extensions
• Manufacturing 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

• 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
  • Coordination of all new tooling and equipment
  • Coordination 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:
  • 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

• Senior Packaging Engineer: B.S. 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. in the same fields 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 simultaneously
• High level of written and verbal communication 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