Process Engineer I: API Process Development

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

Job summary

System One is seeking a Process Engineer I - Process Development in Paulsboro, NJ to join their manufacturing team.

The role focuses on evaluating, designing, and implementing scalable processes transitioning from development to production, with emphasis on safety, quality, and efficiency.

Direct-hire, onsite position offering $80k-$95k with opportunities to improve yields and support API production.

Qualifications

• BS in Chemical Engineering or equivalent technical degree.
• 3+ years manufacturing or process engineering experience in pharmaceuticals or batch processing.
• Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint).
• Knowledge of equipment, technical concepts, and procedures within bulk API batch manufacturing.

Responsibilities

• Evaluate, design, and implement elements of new or improved processes as they are transferred from development to production.
• Monitor manufacturing processes with production support and ensure compliance with safety and quality standards.
• Collaborate with cross-functional teams and external customers to implement safe, efficient processes for consistent API supply, prioritizing safety, quality, yields, turnaround times, and productivity.
• Lead process improvement efforts to enhance yields and lower production costs.
• Contribute to design and oversight of scale-up and validation runs in the manufacturing plant.
• Collaborate with Project/Facilities Engineering during front-end design, PHA, design reviews, commissioning, start-up, and operator training.
• Use root cause analysis tools to lead troubleshooting related to processing and equipment, gathering information and compiling reports.
• Write and review Batch Records, Process Safety Information, Process Validation Protocols, Operator training, and other technical reports.
• Collaborate with the EHS group on environmental, health, and safety aspects of new processes and modifications, including emission calculations.
• Develop process performance tracking procedures and analyze existing data for optimization.

Skills

Process engineering

Pharmaceutical manufacturing

Batch processing

Root cause analysis

Microsoft Office

Cross-functional collaboration

Education

BS in Chemical Engineering

Tools

Batch Records writing

Process validation

Job description

System One is seeking a Process Engineer I - Process Development in Paulsboro, NJ to join their manufacturing team.

The role focuses on evaluating, designing, and implementing scalable processes transitioning from development to production, with emphasis on safety, quality, and efficiency.

Direct-hire, onsite position offering $80k-$95k with opportunities to improve yields and support API production.