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 requiredExperience working in or supporting pharmaceutical operations required minimum of 4 years6+ 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 Assessments5+ years of expertise working process related Investigations and change controls.Strong communication skills, working with a team, and accountable for their workComfortable wearing proper PPE and working in a Laboratory time in Laboratory will fluctuatePay : 68-70 / hr.
Job#83568