QA Process&SW Validation Engineer

Are you looking for a career that matters? We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world. Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives. Process Quality Assurance & SW Validation Engineer ensures that all manufacturing processes and supporting Computer systems are approved and validated, as well as facilities and equipment, producing a product that fulfills all the applicable internal and regulatory requirements. Essential Duties and Responsibilities Evaluate the change request and compile the impact assessment for QA/QC area for the Process and Design Change Control; compiles the execution and implementation phases ensuring it is correctly addressed; Assure that new or modified processes, Computer Systems and Automated Excel Spreadsheets and test methods are designed and validated in compliance with the Standards and internal Baxter Requirements, reviewing and approving related requirements and specifications documents; Define and document the validation strategy of Manufacturing Processes, Facilities/Utilities/Critical System, Computer System Validation and Automated Excel Spreadsheet, preparing validation plans and reports; Collaborate with different departments providing input for the compliance of the manufacturing processes, Software Systems and Operating Procedures. Qualifications University degree in Engineering in Mechanical / Material / Chemical or related field, or equivalent degree; Experience of 3-4 years in a similar role in medium / large company in medical or pharmaceutical sector; Knowledge of Applicable Quality System requirements; Knowledge of European Medical Device Directive 93/42/EEC; Basic knowledge of hemodialysis products; Fluent English (written, spoken, read); Able to work in a team and Problem Solving Oriented; Good communication skills and able to liaise with the different functions involved; Person capable to take ownership of assigned tasks from beginning to end; Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information. ...