Senior Technical Specialist - Process Validation

--- base: meta-keywords: meta-viewport: width=device-width, initial-scale=1.0 title: Senior Technical Specialist - Process Validation ---   Senior Technical Specialist - Process Validation ================================================= Senior Technical Specialist - Process Validation -----------------------------------------------------   Shape the Future of Mechanical Circulatory Support   Join Abbott's Heart Failure business and play a key role in bringing the next generation of Circulatory Support Systems from development into global manufacturing.   Become part of a great team which is responsible for establishing and maintaining processes along the entire supply chain and manufacturing of life-supporting medical devices which are based on the fascinating technology of magnetic levitation. With your work you’ll ensure our products and processes meet the high standards of our industry and are inline with our policy “built as intended for your family”. In your role you will be interfacing and collaborating with cross-functional teams in Switzerland and the USA.   MAIN RESPONSIBILITIES Accountable for process validation planning and execution including supplier process validations, e.g. Master Validation Planning (MVP/MVR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ) and Supplier Process Validation (SPV) Creation and maintenance of validation documentation, e.g. validation protocols, validation reports and supporting documentation such as change orders, risk analysis, deviation reports, etc. Maintain a strong presence on the manufacturing floor, working directly with processes, equipment, and operators to execute validations, investigate issues, verify process performance, and drive practical, data-driven improvements Lead Test and Inspection Method Validation activities (TMV/IMV) Support risk management activities such as process Failure Mode and Effects Analysis update