Process Engineering, Scientist Brunswick, NJ

Process Engineering, Scientist job at SOKOL GxP Services. New Brunswick, NJ.

The Process Engineering Scientist supports MS&T in API and Drug Product (DP) development-to-launch, focusing on oral solid dosage processes. Key duties include experiments, risk assessments, data analysis, validation, tech transfer, and change controls. Requires a BS in a science field, 4+ years in pharma operations, and 6+ years of DP technical experience. Strong communication skills, accountability, and comfort working in labs with PPE and hazardous materials are essential.

• 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.

• Bachelor's Degree in a Science Related field;
• 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.
• Experience working in or supporting pharmaceutical operations requires - minimum of 4 years.
• Comfortable 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.

• Competitive hourly rate: $51.81 – $65.81/hr (W-2 only, no C2C)
• Hybrid schedule (50% onsite)
• Working Hours:
  
  Monday - Friday, business hours
• 12-month contract with possible extension
• Health benefits, holiday pay, and 401(k) program
• Paid time off (UTO) and professional development support
• Employee referral bonus program
• Opportunity to contribute to high-impact projects with a leading biopharma company