Process Engineer I - Pharma API Process Development Onsite

System One, Inc.; Paulsboro (NJ); On-site; USD 80,000 - 95,000; Full time

Job summary

System One, Inc. in Paulsboro, NJ is seeking a Process Engineer I - Process Development to evaluate, design, and implement processes transitioning from development to production. This direct hire, onsite role offers a compensation range of $80,000 to $95,000.

You will monitor manufacturing, ensure safety and quality, collaborate with crossfunctional teams, lead process improvements, and participate in scale-up, validation, and documentation for API production.

Qualifications

• B.S. in Chemical Engineering or equivalent degree.
• Minimum of 3 years’ manufacturing or process engineering experience in pharmaceuticals or batch processing.
• Advanced knowledge of Word, Excel, and PowerPoint.

Responsibilities

• Evaluate, design, and implement elements of new or improved processes transitioning from development to production.
• Monitor manufacturing processes and provide production support while ensuring safety and quality.
• Collaborate with cross-functional teams to implement safe, efficient processes for a consistent API supply.
• Lead process improvement to enhance yields and reduce production costs.
• Contribute to scale-up and validation runs in the manufacturing plant.
• Collaborate with Engineering during front-end design, PHA, design reviews, commissioning, start-up, and training.
• Use root cause analysis to troubleshoot processing and equipment issues.
• Prepare Batch Records, Process Safety Information, Validation Protocols, and training materials.
• Coordinate with EHS on environmental, health, safety aspects and emission calculations.
• Develop process performance tracking and analyze data for optimization.

Skills

Process engineering

Manufacturing experience

Batch processing

Education

B.S. in Chemical Engineering

Tools

Microsoft Office

Job description

System One, Inc. in Paulsboro, NJ is seeking a Process Engineer I - Process Development to evaluate, design, and implement processes transitioning from development to production. This direct hire, onsite role offers a compensation range of $80,000 to $95,000.

You will monitor manufacturing, ensure safety and quality, collaborate with crossfunctional teams, lead process improvements, and participate in scale-up, validation, and documentation for API production.