Main Responsibilities:

• Provide engineering and technical support for complex production and process equipment for GMP Operations (? 50L process equipment)
• Develop process excellence techniques to identify systematic issues. Track trends and implement equipment and/or process enhancements that will improve efficiency, product yield, and equipment reliability.
• Lead in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process nonconformities.
• Owner of allocated ETS record with low to medium impacts
• Review evaluations and advice on the selection of suitable equipment for optimized, balanced line performance and makes final recommendations to management.
• Provide technical leadership of cross functional teams (Technical Services/QA/C&Q) on installation & qualification of new equipment within GMP Operations
• Perform complex technical work including the design, manufacture and operation of equipment and systems.
• Initiate changes in agreement with GMP Operations in order to improve the current production on different aspects (e.g. cost-wise, time-wise or with handling)
• Support process and system owners on design and characterization of new innovative equipment and processes and follow their implementation towards a GMP environment
• Provide technical expertise across a broad range of engineering areas.
• Support GMP Operations on SAP tasks in order to update equipment repair histories, provide technical data updates, and input necessary changes to equipment bill of materials.
• Support the creation, processing, and closing of Quality Issues related to GMP production. Support the creation/update of SOPs, WIs and other relevant documents according to GDP.
• Support GMP Operations in various emergency situations during production such as ordering materials, label creation and coordination with other departments such as QA, QC or WH