Mario Biondo

Senior Process Engineer - Packaging Process Improvement Specialist @GSK

Responsability:\\\\n- Change Request management for changing process, equipment and technologies as part of the process improvement development of the manufacturing area.\\\\n- Project Management – definition of project objectives and strategies according to timelines and milestones.\\\\n- Point of contact as Subject Matter Expert (SME) for global / local GSK stakeholders for investigations, implementation of new technologies and technical support.\\\\n- Reference point of packaging engineering department for projects as crack analysis on vials/PFS, risk of sterility loss and product potency loss.\\\\n- Defining critical system parameters and providing adequate support to the department in managing activities to obtain the correct implementation, in terms of time, quality and productivity (Lean Manufacturing application).\\\\n- Technical contribution to prepare/review SOPs documentation of current and new processes.\\\\n- Ensure continuous improvement and problem shooting. Managing new packaging material development and qualification tests.\\\\n- Definition and support on IQ/OQ and Process Qualification activities.\\\\n- Collaborating in the Deviation Reports Management to facilitate the identification of root causes and possible corrective and preventive actions (CAPA\'s), helping at the same time to implement all the technical and organizational solutions aimed at reducing the number of deviations.\\\\n- Managing the daily and monthly GEMBA to ensure continuous improvement and problem shooting.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n