Senior Process Engineer

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• Oversee/facilitate the change management process and ensure all applicable deliverables are captured/documented to release injection molded components.
• Update BOM, drawings, and manufacturing assembly procedures accordingly.
• May facilitate the design or updates to existing production assembly fixtures.
• Author protocols, facilitate/execute qualification activities, and report documentation.
• Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, as well as production yields for existing products.
• Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.
• Interact with product design and development personnel to ensure that processes and designs are compatible.
• May develop and conduct statistical analysis or recommend additions to document work.
  

Responsibilities

• Oversee/facilitate the change management process and ensure all applicable deliverables are captured/documented to release injection molded components.
• Update BOM, drawings, and manufacturing assembly procedures accordingly.
• May facilitate the design or updates to existing production assembly fixtures.
• Author protocols, facilitate/execute qualification activities, and report documentation.
• Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, as well as production yields for existing products.
• Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.
• Interact with product design and development personnel to ensure that processes and designs are compatible.
• May develop and conduct statistical analysis or recommend additions to document work.
  

Requirements

• Bachelor's degree with a minimum of 4 years of experience in a regulated environment, OR an advanced degree with a minimum of 2 years of experience.
• Develop manufacturing processes that are applicable to statistical process control and may develop those techniques, including the measurement systems.
• Must be open to travel domestically or internationally to perform duties as required.
• Lead the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations.
• This can include scouting and feasibility work, material selection, process and equipment selection, tooling/fixture and equipment installation, and assessment of inputs, outputs, and alignment to requirements.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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