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The Site Validation Lead provides the site with Subject Matter Expert (SME) knowledge and skills, of specific pharmaceutical processes or process technologies and project management (e.g. Aseptic Processing changes and new projects, Isolator Technology, Trasis synthesis Units, Vial Dispensing Units, etc.).
Your responsibilities include, but are not limited to: Validation * Responsible for the generation upkeep and execution of the Site Validation Masterplan each year * Responsible for coordinating tasks linked to execution of activities listed on site validation masterplan * Generates or Approves validation protocols and reports under their area of responsibility (as needed). * Provides technical expertise for validation activities around technologies within area of responsibility. * Takes the lead on determining validation strategy for new processes and technologies Launch & Transfer * SME for specific Technology Platform or pharmaceutical processes following process product/process transfer or handover from launch to commercial production. Stewardship - for technologies assigned: * Acts as the SPOC for the interface with global MS&T network and with the technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment. Collaborate with technical development, other sites, and global MS&T network to facilitate transfer of technical knowledge. * Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE). * Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements. Training: * Provide technical training and education for Process Experts and production operators.