Process Engineer II
MedImmune
(Frederick, Maryland)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
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