Process Engineer II

As the global biologics research and development arm of AstraZeneca, MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic including respiratory, inflammation, and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.

The Process Engineer is responsible for providing equipment engineering support for processes at MedImmune's Biopharmaceutical facility located in Frederick, Maryland.

• The Process Engineer's core responsibilities include resolving technical issues with the equipment as it pertains to the process requirements, optimizing/improving the process equipment, identifying root causes for deviations, defining corrective/preventative actions and implementing new/replacement equipment as required for existing or new (tech transfer) processes.
• The Process Engineer leads any Validated System Change Requests (VSCRs) associated with the equipment he/she is responsible for.
• The individual is expected to possess strong technical skills and experience with biopharmaceutical unit operations and equipment.

• 1-5 Years of experience supporting a Biopharmaceutical Manufacturing plant.
• Experience with commercial large scale (10k Liter+) Biopharmaceutical equipment desired. Experience with GMP change control and documentation. Experience in a highly automated environment is a plus.
• Position level commensurate with experience.
• BS in Engineering or Life Sciences
• Resolve/identify equipment related issues and improvements for biopharmaceutical production * Identify root cause, corrective and preventative actions for equipment caused deviations
• Create/update Equipment Operation and Maintenance documentation
• Select, design, and implement new or replacement equipment
• Support FAT, SAT, commissioning, and validation activities
• Provide technical support during cGMP audits
• Train manufacturing staff on equipment operation
• Assist with support of control systems
• Strong Troubleshooting skills
• Excellent Mechanical Knowledge
• Good Communication and Teamwork skills