The Technical Services and Manufacturing Sciences (TSMS) Operations Engineer will provide direct technical support to manufacturing operations on the production floor in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs.
Requirements
- Provide real-time technical support to manufacturing operations staff during production activities
- Assist with scaling up and transferring processes into manufacturing
- Support equipment setup, operation, and troubleshooting
- Review and assist with GMP manufacturing documentation
- Monitor Process Data during manufacturing operations and escalate deviations or concerns
- Assist with technical troubleshooting of routine process issues and support root cause analysis activities
- Support Process Performance Qualification and Continuous Process Verification activities
- Participate in cross-functional teams to support manufacturing operations and process improvements
- Assist with impact assessments of minor changes to processes, equipment, or procedures
- Support training and development of manufacturing operations staff on technical procedures and best practices
- Maintain detailed records of technical support activities and communicate findings to senior technical staff
Benefits
- Paid time off
- 401k matching
- Retirement plan
- Equal opportunity employer