Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity
- Bachelor’s degree in Engineering and 5 years of Engineering experience.
- Working experience with Bioprocessing Equipment such as Bioreactors, Centrifuges, Homogenizers, Chromatography skids, filtration skids, clean in place systems, and their associated instrumentation.
- Comprehensive knowledge of standard maintenance practices, preferably using Maximo maintenance management system.
- Knowledge of standard calibration practices. Ability to interpret calibration documentation and define calibration criteria based on equipment and process requirements.
- Working experience supporting routine manufacturing operations in a highly regulated biotech or pharmaceutical environment.
- Ability to lead troubleshooting initiatives for equipment and operational issues.
- Experience defining, managing and documenting equipment related changes.
- Excellent interpersonal and time management skills to manage changing priorities from multiple stakeholders.
- Ability to read Piping and Instrumentation diagrams (P&ID)