Process Engineer

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. The Process Engineer is also responsible for the monitoring of manufacturing processes while providing production support and ensuring compliance with safety and quality standards. 

Core Responsibilities:                                                                                                                   

• Collaborates with Veranova 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, with essential considerations given to safety, quality, optimizing process yields, turnaround times, and productivity.
• Monitors ongoing manufacturing operations to help ensure safety, quality and yield objectives are met. 
• Leads process improvements efforts which improve yields and/or lower production costs, enhancing the overall efficiency and cost effectiveness of production processes.
• Contributes to the design and oversight of scale-up and/or validation runs in the manufacturing plant.
• Collaborates 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.
• Using root cause analysis tools, leads troubleshooting efforts related to processing and process equipment problems while gathering relevant information and compiling necessary reports.
• Writes and reviews Batch Records, Process Safety Information, Process Validation Protocols, Operator training, and other technical reports.
• Collaborates with the EHS group on environmental, health and safety related aspects of new processes and process modifications; performs related emission calculations.
• Develops process performance tracking procedures and analyses existing data for optimization potential.

Qualifications: 

Required

• B.S. in Chemical Engineering or equivalent technical degree.
• Minimum of 3 years’ manufacturing or process engineering experience in pharmaceuticals or batch processing.
• Knowledge of FDA/cGMP guidelines and practices.
• Advanced knowledge of Microsoft Office Products (Word, Excel and PowerPoint).
• 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.
• Strong statistical analysis skill.
• Strong Failure Mode and Effect and Root Cause analysis skills.