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Process Engineer (West Deptford, NJ)
The Process Engineer is responsible for the design and implementation of elements of new or improved processes as they are transferred from development to production.
Core Responsibilities:
Required
Core Responsibilities:
- Collaborate with cross functional teams to develop safe, efficient, practical and commercially viable processes to generate a consistent quality API supply fit for its intended use, with essential considerations given to optimizing process yields, turnaround times, and productivity.
- Lead process improvements efforts which improve yields and/or lower production costs, enhancing the overall efficiency and cost effectiveness of the Pharmaceutical Materials production processes.
- Design and conduct a variety of experiments or plant trials to define process conditions that match or improve plant capabilities to run commercial processes.
- Contribute in pilot and validation runs in the manufacturing plant
- Collaborate with Project/Facilities Engineering in capital projects during front-end design (URSs, PFDs, M&E Balances), PHAs, design reviews, commissioning, start-up and operator training
- Lead troubleshooting efforts related to processing and process equipment problems while gathering relevant information and compiling necessary reports.
- Write and review Batch Records, SOPs, Process Validation Protocols, and other technical reports
- Collaborate with the EHS group on environmental, health and safety related aspects of new processes and process modifications; performs related emission calculations
- Develop process performance tracking procedures and analyses existing data for optimization potential
Required
- B.S. in Chemical Engineering or equivalent technical degree required.
- Minimum of 3 years manufacturing or process engineering experience in Pharmaceuticals required.
- Advanced knowledge of Microsoft Office Products (Word, Excel and PowerPoint) required.
- Knowledge of commonly used equipment, technical concepts and procedures within bulk API batch manufacturing.
- Team oriented and able to work efficiently in a project driven environment.
- Strong verbal and written communication and presentation skills.
- Excellent organization skills and ability to prioritize and multi-task.
- Knowledge of FDA/cGMP guidelines and practices.
- Strong statistical analysis skillset.
- Strong Failure Mode and Effect and Root Cause analysis skills.
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