Job Details

  • Title: Engineering - Process Engineer
  • Code: RCI-30760-1
  • Location: New Brunswick New Jersey (NJ) 08903
  • Posted Date: 03/09/2020
  • Duration: 12 Months
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  Job Description

  • Provide technical support to the External Manufacturing Organization and assigned contract manufacturing organizations (CMO's), ensuring the transfer of robust manufacturing and packaging processes to CMO's and/or Client sites.
  • Ensure continuity of supply from assigned CMO's and support ExM projects and objectives.

Responsibilities include:
  • Responsible for personal, colleague, and workplace safety.
  • Provide input to ExM MT colleagues for potential OpEx projects; assist with project execution and completion.
  • Assist ExM MT with product robustness efforts and resulting projects and initiatives.
  • Represent ExM MT and work closely with the SRM, Quality, and other team members in developing and executing projects, strategies, and OpEx problem- solving efforts.
  • Track CMO investigations and CAPAs from inception to completion; assist ExM MT staff as necessary in problem resolution.
  • Gather information as needed from the CMO for product transfer, investigation / CAPA, or other MT projects and initiatives.
  • Supports efforts to meet / exceed ExM MT objectives.

Desired Background:
  • Ability to assist / lead the process to successfully complete investigations and related CAPAs.
  • Knowledge of OSD manufacturing and/or packaging operations, including but not limited to knowledge of cGMPs, validation, and quality systems.
  • Bachelor’s degree or higher in a scientific discipline, preferably an engineering or pharmacy degree.
  • Prior experience in the pharmaceutical industry, preferably in MT, Packaging Technology (PT), OSD manufacturing, and/or OSD packaging.
  • Basic regulatory knowledge, particularly with respect to the transfer of manufacturing and/or packaging operations.
  • Ability to effectively communicate orally and in writing;