Lean Manufacturing Engineer - GMP - Engineering Resource Group

Description

• Permanent position for a Lean Manufacturing Engineer to lead the company toward a LEAN manufacturing environment.
• Assist with day-to-day production support and improvements.
• Lead concurrent engineering practices with Engineering to successfully transfer New Product Introductions (NPIs) within manufacturing.
• Perform and complete supplier qualifications, which includes, but not limited external process capabilities studies.
• Perform and complete process IQ/OQ/PQ qualifications, which may include PPQ validations.
• Review, create, revise, etc. manufacturing documentation (i.e. drawings, Work Instructions, Travel Tickets).
• Execute LEAN manufacturing techniques and principles:
• Facilitate a “self-directed” manufacturing environment.
• Develop principle work standards and line balancing for increased productivity.
• Complete value stream mapping exercises to determine, define; including plans to achieve future state.
• Some design and development of manufacturing fixtures and equipment.
• Identify manufacturing cost reductions and provide ROI justifications for change.

Requirements

• BS Manufacturing, Mechanical Engineering, or equivalent.
• Minimum of 3 years of experience utilizing Lean Manufacturing initiatives in production environment.
• Green Belt certification in Six Sigma and/or Lean Manufacturing preferred.
• Understanding of GMPs preferred.
• Ability to multi-task to manage multiple projects and various project activities.
• Strong communication, presentation, and interpersonal skills.
• Strong analytical and technical skills.
• Strong computer skills, including knowledge of SolidWorks required.
• Ability to understand production processes and should be aware about the product operations.
• Ability to follow all the internal, FDA’s GMPs, and ISO quality standards guidelines strictly.

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