Process Engineering, Scientist

Our client, a leading pharmaceutical company, is hiringProcess 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

The post appeared first on .