Process Engineer I

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

Job Title: Process Engineer I - Process Development
Location: Paulsboro, NJ
Type: Full-time (Direct Hire)
Compensation: $80,000 - $95,000
Work Model: Onsite – onsite

Overview:
Contract Development and Manufacturing Organization is seeking a Process Engineer to join their team on a direct hire basis.

Responsibilities

• The Process Engineer is responsible for the evaluation, design, and implementation of elements of new or improved processes as they are transferred from development to production.
• Monitor manufacturing processes while providing production support and ensuring compliance with safety and quality standards.
• Collaborate with cross-functional teams and external customers to implement safe, efficient, practical, and commercially viable processes to generate a consistent quality API supply fit for its intended use, prioritizing safety, quality, process yields, turnaround times, and productivity.
• Lead process improvement efforts to enhance yields and lower production costs, improving overall efficiency and cost-effectiveness of production processes.
• Contribute to the 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 efforts related to processing and process equipment problems, gathering relevant 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 process modifications, including emission calculations.
• Develop process performance tracking procedures and analyze existing data for optimization potential.

Requirements

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

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.