Process Engineering, Scientist

Overview

On Site
USD 65.00 - 75.00 per hour
Contract - W2

Skills

Recruiting
Process Engineering
SAP BASIS
API
Data Analysis
Test Plans
Testing
Root Cause Analysis
Manufacturing
Change Control
Data Processing
Writing
OSD
Evaluation
Management
Risk Assessment
Science
Pharmaceutics
Communication
Accountability

Job Details

Our client, a leading pharmaceutical company, is hiring Process Engineering, Scientist on a contract basis.
Job ID: 83568

Work Location:
New Brunswick, NJ (Hybrid Working Model)

Summary Responsibilities:
  • 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 assessments, Nitrosamines Risk Assessment, Elemental Impurities Risk assessment etc.
  • 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

Required Qualifications:
  • 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.
  • Bachelor's Degree in a Science Related field required
  • Experience working in or supporting pharmaceutical operations required-minimum of 4 years
  • Comfortably wearing proper PPE and working in a Laboratory -time in Laboratory will fluctuate
  • Strong communication skills, working with a team, and accountable for their work

Pay Rate: $65- $75/hour W2

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