Senior Process Engineer

Job Functions:

• 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.
• 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. 
• Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing) & work with vendors and suppliers to define requirements and understand functional specifications.

Candidate Requirements:

• Knowledge of data management tools and RCM. 
• 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. 
• CMO/CDMO experience 
• Technical and/or lean six sigma certifications