Process Engineering ScientistTSR Consulting • New Brunswick, NJ, United States
Process Engineering Scientist
TSR Consulting • New Brunswick, NJ, United States
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job_description.job_card.job_descriptionBachelor'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
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 :
Pay : 68-70 / hr.
Job#83568
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Scientist Engineering • New Brunswick, NJ, United States
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