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Process Engineer

1 month ago

Riverview, United States Planet Pharma Full time

The Process Engineer, under the direction of the manufacturing engineering supervisor, will work with the implementation of new product development and process implementations. The documentation/qualification activities include but not limited to: feasibility studies, validation protocols, standard operating procedures changes, training material, drawings, raw material specifications updates etc. This resource will manage the site timeline for the project and will participate in the project management activities. This contractor will engage with suppliers and manage all external responsibilities.

  • Design and develop processes and equipment to improve productivity.
  • Provide process control measures through validation plans, data analysis, and statistical process control techniques.
  • Documentation and communication skills to manage projects, vendors, test plans, and present cost justifiable action plans and reports.
  • Organizational skills to manage/prioritize task assignments, amongst unplanned troubleshooting tasks.
  • Maintain a clean and safe work environment for self and others.
  • Display a sense of urgency, sound judgment, and pride in workmanship.
  • Display self-motivation and the ability to work independently and as part of team.
  • Utilize upward communication to keep supervisor informed of task status, job-related problems and other information related to work activity.


Requirements:

  • B.S. Mechanical or Electrical Engineering
  • Minimum 2 years of experience preferably in a medical manufacturing industry
  • IQ/OQ/PQ
  • Understanding of FDA regulations surrounding the manufacture of medical devices and GMPs.
  • Strong technical expertise on manufacturing equipment and process
  • Project management experience


Preferred Skills/Qualifications:

Experience using Microsoft Office Software, Agile, Minitab or equivalent QMS/statistical analysis software