Sr Engineer / Validations

Job Category: Quality Assurance/Safety Company: Baxter Healthcare Reference Code: 30561BR Sr Engineer / Validations Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. This position is responsible for validation and change control of manufacturing equipment, processes and automation systems in an FDA regulated environment.  Prepare, direct, analyze and review validation protocols and activities for new and modified systems. Utilize project management skills to coordinate activities for multiple projects to ensure timely completion in support of departmental / plant and divisional goals. Provide expertise in manufacturing equipment, processes and hardware / software systems with respect to validation / qualification. Ensure regulatory compliance with respect to validation and process change control through evaluation and auditing of current procedures and documentation. QUALIFICATIONS: BS in Electrical, Mechanical, Industrial Engineering or a related field with 3-5 years validation experience. Candidate must possess a thorough knowledge of validation principles, manufacturing processes and quality systems including cGMP's.CQE / Six Sigma Certification / Black Belt Certification / knowledge & experience with DOE,  E-Chip and MINITAB experience a plus.  Strong project management, interpersonal and communication skills required. Must not be allergic to cephalosporins or penicillins. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.