Drug Product Manufacturing Engineer

Job Description

Title : Drug Product Manufacturing Engineer

Duration : 12+ months

Location : New Brunswick, NJ (2-3 days onsite)

Interview mode is Video over Teams

Looking for a candidate with 6+ years of drug product 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.

Responsible for supporting pharmaceutical Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.

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 assessment, 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

Education and Experience Required :