Engineer - Combination Products

6 days ago


Thousand Oaks, California, United States AIC Full time

About the Role:

The Senior Engineer - Physical Methods will be responsible for leading engineering activities required for the development, qualification, validation, and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging parts.

Key Responsibilities:

  • Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
  • Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
  • Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
  • Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
  • Provide experienced support for investigations as well as new process development required to improve manufacturing operations.
  • Coordinate test method development and delivery with selected contractors.
  • Ensure that qualification parameters are met for product assembly requirements.
  • Support development of cost estimates for new processes, gauges, and equipment development used in generation of capital request documentation.
  • Generate procedures necessary to support department and new process equipment.
  • Provide experienced training to individuals in the operation and maintenance of processes, test methods, and equipment introduced to Quality Control and/or the manufacturing department.
  • Participate in and assume responsibilities of team functions as assigned.
  • Generate/author and be responsible for the Test Method documents.
  • Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design.

Requirements:

  • M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry.
  • Excellent written and verbal communication skills.
  • Ability to work in a highly matrixed team environment.
  • 2 years of experience in the biotechnology/pharmaceutical industry.
  • 2 years of experience in equipment, method, and mechanical design.
  • Technical writing experience.
  • Experience with SolidWorks (or other 3D-CAD software).
  • Experience with combination products and regulatory requirements.
  • Experience applying Minitab (or other statistical software packages).


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