Job Description:
Our client is seeking a 5+ year process development engineer to join their Development Team and work on process development, optimization, process scale-up, and technology transfer of novel products and processes into Manufacturing. This person will be responsible for the design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices. They will manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies and establish operating specifications, defines process windows, and improves manufacturing techniques/processes. This Process Engineer will also be responsible for writing and reporting of Protocols, Reports, SOP’s, and Work Instructions, as required, and conducts or coordinates testing and execution of identified activities. General support of Deviation Management, CAPA, and Change Control activities is required. The Client would also like to see 3 years of relevant cleaning validation experience specifically utilizing a CIP cleaning system.
Skills:
- Process Development
- Manufacturing
- Equipment Validation
- Cleaning Validation (CIP Systems)
Education:
Bachelor’s degree
On-Site: Process Development Engineer (234444)
