Job Details

  • Title: Assistant Process Engineer
  • Code: RCI-41693-1
  • Location: New Brunswick, NJ 08903
  • Posted Date: 09/17/2021
  • Duration: 6 Months
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  Job Description

  • Candidate MUST HAVE drug development experience.
  • A Ph.D/Master degree preferred with lyophilization development and/or filter validation experience is preferred.

Job Description

  • Work independently to assist in investigation of process deviations, data trending, change controls and other documentation.
  • Perform manual or automated process performance data extraction, reporting and analysis.
  • Coordinate the execution of process validation protocols, including scheduling, communication, coordination of sample delivery and data collection.
  • Coordinate activities between Manufacturing Technology, Manufacturing operating groups, Supply Chain, and QA/QC to meet project timelines.
  • Achieve high customer satisfaction through effective communication of both technical and non-technical topics with all levels of the organization both verbally and in writing.

Requirements:

  • BS degree in science or engineering related to biopharmaceutical process technology with minimum of 3-5 years biopharmaceutical or equivalent industry experience.
  • Advanced degree is preferred.
  • Experience with lyophilization development, filter validation, electronic database systems and statistical analytical packages is highly desirable.
  • Excellent verbal & written communications skills.
  • Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization.
  • Broad knowledge of biopharmaceutical facility design and manufacturing operations is highly desirable.
  • Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is desirable.