Assistant Process Engineer

Job Post Index 23C30A-Sy##
Location New Brunswick, NJ
Description: 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.
Skills: Qualifications
  • BS degree in science or engineering related to biopharmaceutical process technology with minimum of 3-5 years biopharmaceutical or equivalent industry experience; OR
  • A Ph.D/Master degree preferred with lyophilization development and/or filter validation experience is preferred.
  • Must have drug development experience
  • Experience with lyophilization development, filter validation, electronic database systems and statistical analytical packages is highly desirable.
  • Excellent verbal and 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.
  • Prefer experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors .

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