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PROCESSING APPLICATION
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Job Requirements of Process Engineering - Scientist:
-
Employment Type:
Contractor
-
Location:
New Brunswick, NJ (Onsite)
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Process Engineering - Scientist
Careers Integrated Resources Inc
New Brunswick, NJ (Onsite)
Contractor
Job Title: Process Engineering - Scientist
Location: New Brunswick, NJ 08903
Duration: 12 months+ (with possibility of extension)
Pay Range: $51.81 - $65.81/hr. on W2
Work Schedule:
Job Summary:
Responsible for supporting pharmaceutical Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.
Duties and Responsibilities:
Education, Experience and Skills:
Location: New Brunswick, NJ 08903
Duration: 12 months+ (with possibility of extension)
Pay Range: $51.81 - $65.81/hr. on W2
Work Schedule:
- Monday – Friday (normal business hours).
- 50% onsite is required.
Job Summary:
Responsible for supporting pharmaceutical Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.
Duties and Responsibilities:
- Responsible for supporting MS&T API and 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 by generating test plans, change controls, executing and compiling results into reports.
- Support validation efforts in the development of validation strategies and testing plans.
- Provide input into process-related investigations and complete MS&T investigations as required.
- Advise on root-cause analysis of undesired trends or deviations related to process equipment.
- Support monitoring of studies at manufacturing areas and Contract Manufacturers, as needed.
- Support the Change Control process.
- Position does handle hazardous material.
Education, Experience and Skills:
- Bachelor'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, supporting during experimental phase and process validation in the Pharma space for oral solids.
- Experience writing OSD strategies, study plans, study reports, validation protocols, and validation reports.
- 4+ years of expertise in data evaluation and managing Risk Assessments.
- 5+ years of expertise working process-related investigations and change controls.
- Comfortable wearing proper PPE and working in a laboratory — time in laboratory will fluctuate.
- Strong communication skills.
- Works well with a team.
- Accountable for their work.
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