Senior Process Engineer

Job Responsibilities: 

• Leading the packaging equipment specification, procurement, installation and qualification activities. This includes managing portions of the capital budget and providing routine project updates.  
• Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.   
• Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.  
• Mentor and train other team members.  
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.   
• Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.  
• Participate and report to a cross-functional team to advance production activities.   
• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.   
• Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing)   
• Execute engineering studies, recipe development, and validation test cases.  
• Work with vendors and suppliers to define requirements and understand functional specifications.  
• Understand manufacturing needs and adapt to the changing needs of the manufacturing environment.  
• Work flexible hours for the coverage of the production facility.  

Qualifications:  

• Bachelor’s degree or higher in chemical, electrical, or mechanical engineering, biochemistry, bioengineering, or related scientific field
• 5+ years’ experience in biopharmaceutical or other GXP regulated industry
• Knowledge of data management tools and RCM.