Engineer I, Process
- Research Triangle Park, NC
- Department: Engineering
- Region: US
The position provides responsible engineering support for GMP (Good Manufacturing Practice) equipment in a Cell Culture and/or Purification area including bioreactor, perfusion, chromatography, centrifugation, UF/DF, solution preparation and filtration operations. Designs, specifies, installs, and commissions new equipment and provides engineering technical support and troubleshooting for cell culture or purification processing equipment including associated automation. Engagement and support of process tech transfers is required to ensure manufacturing equipment meets process requirements. Investigates process or equipment failures and implements changes to avoid future occurrences. Provides support for new equipment evaluations and process improvement studies. Investigates equipment failures and implements changes to avoid future occurrences. Provides support for site and global regulatory inspections, as needed.
Rotating on-call support during off hours is required.
Bachelor’s Degree with 0-2 years related industry experience or an MS Degree with a minimum of 0 years related industry experience.
- Practical knowledge and application of GMP and EMEA regulations.
- Competency in MS Word, MS Excel, MS Power Point and MS Project.
- Excellent oral and written communication skills.
- Ability to work rotating shifts, extended shifts and weekends as needed.
The Engineer I, Process is responsible for providing engineering support to Flexible Volume Manufacturing and other purification or cell culture areas containing biological processing & support equipment.