Product Technical Transfer Lead job in Huntington
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||West Virginia (WV)|
Provides to the Site the specialist knowledge, as Subject Matter Expert, of specific IOL manufacturing processes or process technologies (e.g. Molding, CFE, OME, Milling, Welding, Cast/Cure, Package to Order, Plasma) Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies. Plans, designs, coordinates, validates, and implements high technology equipment and/or processes for the production, finishing and inspection of IOLs. Provides engineering support to manufacturing to maintain high yields and minimize downtime of process equipment.|
1. Equipment Selection & Validation - Participate in the definition and selection of manufacturing equipment, through providing input to User Requirements (URS). Responsible for introducing and validating new equipment and/or complex new process projects from design through completion and in regulatory compliance. 2. Compliance/Audit Support - Responsible for putting effective CAPAs in place for compliance actions within the agreed timeline. Maintain work in inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review regulatory documentation. Responsible that work adheres to HS&E requirements 3. Continuous Improvement - Responsible for initiating and driving cost improvement and LEAN Manufacturing initiatives. Responsible for supporting and improving existing processes through process analysis and the application of engineering principles. Responsible to perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies. 4. Project Management - Responsible for project management & planning and for liaising with other departments/plants affected on process and equipment related projects. Also for reporting project status to management and highlighting areas of concern early. Responsible for planning and managing projects to ensure effective utilization of resources and for liaising with R&D and other Alcon facilities to develop and introduce new products and processes. 5. Subject Matter Expert SME for Technology platform - Deep Subject Matter Expertise for specific IOL manufacturing process (e.g. Molding, Milling, OME, etc.) following process product/process transfer or handover from launch to commercial production. Designs and controls optimization projects relevant to his/her specific expertise. Provides SME expertise to perform process characterization to increase robustness and sustainability. 6. Knowledge management/Single Point of Contact (SPoC) for the technology - Owns the knowledge of manufacturing process technologies locally, including any pilot scale, scale up or down, and Design of Experiments (DoE). Provides and assures the fundamental knowledge in the specific area of expertise through the provision of regular training and education programs for Process Experts and Operators. Collaborate with R&D and global MS&T network to facilitate transfer of technical knowledge.Bachelor degree in Engineering/ Physics or related discipline Masters degree in. Engineering/ Physics or related discipline Excellent knowledge of English and proficient in Site local language. Minimum: 7 years experience in high volume manufacturing environment with experience of process engineering, automation implementation and project management Preferred: 5-10 years experience in medical device manufacturing. Experience to include cross site projects and R&D Liaison. Project management and team leadership experience. Regulated industry experience.