Process Engineer

Position Summary

Responsible for establishing manufacturing process capability for new/reformulated products. Support the execution of equipment qualification, cleaning, and process validation programs. Prepare and revise batch records, operating instructions, and cleaning instructions. Conduct process improvement studies in the areas of operational productivity, process control, quality processing, employee safety, process yield improvement, and environmental impact in a lean environment. Test new technologies, processes, controls or prototype equipment and support implementation as appropriate to optimize liquid blending systems. Provide indirect supervision of technicians, interns and operators as required. Develop P&ID’s in support of validation efforts. Develop design of experiment for the purpose of scale-up, trouble shooting, and modifications of new and existing processes.

Duties

• Support the execution of protocols to comply with FDA and cGMP requirements for equipment qualification, cleaning and process validations.
• Responsible for development of lean culture and institution of lean principles.
• Develops plans, design of experiments, and schedules for establishing manufacturing process capability and introduction of new/ reformulated products. Interfaces with Product Development and Production to bring these processes from the research laboratory through scale-up into full scale manufacturing.
• Responsible for research and testing of new technologies or processes appropriate for support of new/existing product manufacture.
• Supports Project Engineering to obtain approval for Capital Appropriation Requests, design specifications and equipment installation.  Provide personnel training, development of manufacturing instructions and start-up of new processes/equipment.
• Responsible for conducting process studies, identifying opportunities for improvement and supporting implementation of findings to optimize liquid blending systems.
• Resolves specific manufacturing deficiencies through troubleshooting and implementation of corrective actions.
• Develops and submits written reports including, objective, experimental, compilation of data, engineering analysis, conclusions and recommendations.
• Monitor and provide solutions in terms of quality, yields, throughput, cycle times, process parameters, cGMP compliance, and safety and environmental requirements.

Required Experience

• Bachelor's degree in Engineering.
• One to five years’ experience in process engineering, production support and/or batch chemical processing.
• Project leadership skills, technical skills and organizational skills required. 
• Familiarity with current Good Manufacturing Practices (cGMPs) and familiarity with FDA regulations preferred. 
• Good communications and interpersonal skills needed.
• Experience in basic unit operations required.

#LI-BN1