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Process Engineering Scientist

Process Engineering Scientist

TSRNew Brunswick, New Jersey, United States
5 hours ago
Job type
  • Full-time
Job description

Our client a major pharmaceutical company is seeking a Process Engineering Scientist on a long term contracting basis

This is a hybrid role based in New Brunswick NJ

Responsibilities :

  • Responsible for supporting pharmaceutical Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams
  • Responsible for supporting MS&T Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.
  • Design and run experiments
  • Perform risk assessments, including but not limited to Material and Process Risk assessment, Nitrosamines Risk Assessment, Elemental Impurities Risk assessment
  • Complete, analyze and present data analysis
  • Support tech transfer activities in the form of generating test plans, change controls, executing and compiling results into reports
  • Supports validation efforts in the development of validation strategies and testing plans
  • Provide input into process related investigations and complete MST investigations as required.
  • Advise on root-cause analysis of undesired trends or deviations related to process equipment.
  • Support monitoring of studies at manufacturing areas, Contract Manufacturers, as needed
  • Support the Change Control process
  • Position does handle hazardous material

Qualifications :

  • Bachelor's Degree in a Science Related field required
  • Experience working in or supporting pharmaceutical operations required minimum of 4 years
  • 6+ years of DP technical experience, support during experimental phase and process validation and the Pharma space for oral solids.
  • Experience writing OSD strategies, study plans, study reports, validation protocols and reports.
  • 4+ years of expertise in data evaluation, 4+ years of expertise managing Risk Assessments
  • 5+ years of expertise working process related Investigations and change controls.
  • Strong communication skills, working with a team, and accountable for their work
  • Comfortable wearing proper PPE and working in a Laboratory time in Laboratory will fluctuate
  • Pay : 68-70 / hr.

    Job#83568

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    Scientist Engineering • New Brunswick, New Jersey, United States

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