LEAD PROCESS ENGINEER

The Lead Process Engineer is expected to be a self-motivated, creative thinker, with excellent analytical skills and a positive approach to process engineering and risk mitigation. Using problem-solving skills and engineering know-how, your tasks will include implementing, troubleshooting, maintaining, and improving process recipe set-up for fluid bed drying, spray drying, and blending operations. This individual must be able to understand the critical chemical and physical changes that occur at bench scale, as well as identify, measure, and analyze the unit operations necessary to achieve transformations at the commercial scale. The Lead Process Engineer must be able to effectively communicate within all levels of the organization as well as with customers.

Responsibilities

• Design, develop and test new products as well as make the transition from development stage to commercial product status.
• Coordinate pre-trial  , manage logistics for trials, process recipe set-up and optimization to drive continuous improvements in process capabilities.
• Assemble and analyze manufacturing data (process parameters and critical quality attributes) to evaluate process robustness.
• Create strategic plans that eliminate identified inefficiencies.
• Lead Process Engineering team to ensure transfer of technology from pilot lab to full-scale commercialization.
• Conduct risk assessments of equipment and processes.
• Collaborate with Quality Team to ensure compliance with applicable safety and quality standards.
• Develop best practices, routines, and innovative solutions to improve production rates and quality of output.
• Coach less experienced engineers, as well as provide technical training to others.
• Assist product in troubleshooting in the event of a problem.
• Gather, analyze and summarize trial data. Submit written reports to internal and external customers.
• Participate in cross-functional team projects with the Sales Department as well as customers.
• Demonstrate ability to take initiative, prioritize objectives from multiple projects, and to adhere to scheduled timelines while maintaining flexibility.
• Utilize Batch Metrics™️ to upload, store, and review data.

Desired Skills and Experience

• BS Degree in Chemical Engineering or related scientific discipline.
• Experience in a cGMP environment.
• Minimum 5 years process engineering experience in a manufacturing environment.
• Experience with BatchMetrics™️ a plus.
• Familiarity with heat transfer, mass transfer, and thermodynamics principles.
• Must be able to work in a fast-paced environment and manage multiple priorities.
• Must be able to identify issues and communicate with all levels of the organization to get them resolved.
• Ability to apply engineering concepts to solve performance problems.
• Must be a strong work ethic and attention to detail.
• Must be reliable.
• Travel between New Jersey and Pennsylvania facilities is required.

Requirements

• Education: BS in Chemical Engineering or Related Scientific Discipline.
• Experience: Experience in a cGMP Environment.