Process Engineer
About The Position
The Process Engineer works to design and efficiently transfer new processes into manufacturing, optimize existing processes, ensuring the achievement of quality, yield, and capacity timelines. Drafts experimental, development, and operational studies to expand expertise in parenteral manufacturing. Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations. Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time. Interfaces with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment. Takes initiative to develop and improve procedures and setups through the change control process. Prepares and reviews technical documents to include but not limited to: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols. Contributes to investigations and deviations related to manufacturing, defines root causes and implements corrective actions. Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required.
Requirements
- Bachelor of Engineering (Chemical)
Responsibilities
- Design and efficiently transfer new processes into manufacturing
- Optimize existing processes, ensuring the achievement of quality, yield, and capacity timelines
- Draft experimental, development, and operational studies to expand expertise in parenteral manufacturing
- Ensure work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations
- Contribute to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time
- Interface with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment
- Develop and improve procedures and setups through the change control process
- Prepare and review technical documents to include but not limited to: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols
- Contribute to investigations and deviations related to manufacturing, define root causes and implement corrective actions
- Troubleshoot and investigate manufacturing problems, monitor the processes and optimize processes as required
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
