Supt, Manufacturing

Job Category: Manufacturing/Production/Operations Company: Baxter Healthcare Reference Code: 32692BR Supt, Manufacturing 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. BASIC FUNCTION:This position is accountable for directing and controlling the manufacturing and development operations associated with Clearshot products within the Cleveland MS facility. This position will also manage all e-beam sterilization activity directly related to the Clearshot program. This position will also be responsible for the successful development and implementation of VHP sterilization of the production line. The position will ensure that all sterility assurance requirements established by the Federal Food and Drug Administration are met and maintained. This is a development program that will lead to a permanent manufacturing operation. All of the development activities related to the Clearshot program will be primary responsibilities. Achieving cost targets, budget objectives and implementation schedules will be the primary focus until the line is operational. Once operational this position will have responsibility for organizing and implementing business and quality systems that will achieve all Corporate and Division profit goals, manufacturing efficiency targets, cost reduction, Customer satisfaction and good employee relations. This position directly and through the Clearshot team will focus on coordinating the multiple development activities that will lead to timely implementation and validation of the Clearshot lines. The incumbent will work closely with counterparts in Quality both locally and at the Division level. The position will also actively interface with the divisional R & D community and the product development group in order to define and clarify manufacturing requirements. The position will have direct and indirect responsibility for successful validation of an integrated manufacturing line. Equipment will include sterilization equipment, barrier isolator equipment, filling/stoppering, as well as vision inspection and packaging equipment. All this equipment has related PLC control along with computerized monitoring systems. The position may require international and domestic travel (15%). This position will be required to interface with division regulatory and with external regulatory agencies including the FDA, but also international regulatory agencies. JOB DUTIES: The Clearshot Superintendent will direct the manufacturing activities of the Clearshot program to assure that all cost, quality and development requirements are achieved. The incumbent will also be responsible to assure compliance to all regulatory requirements for a global product introduction.  The position is also responsible to assure that a safe working environment is maintained both in the stability/development area and in the production area. Responsible for upholding all health/safety policies within the Corporation. Direct supervision responsibilities for Clearshot manufacturing personnel. Develop and assure compliance with budget and implementation schedule. Perform analytical review of all exceptions/development issues and recommend corrective action or alternate courses of action. Approve all specificiations and SOPs applicable to the Clearshot program. Perform equipment troubleshooting and diagnosis. Work closely with counterparts at the divisional level and within the plant to assure that all requirements are properly defined and met. Assist in the preparation of CPAs and CPJs and economic justifications. Provide technical support to the divisional groups for pre-approval inspections from a variety of regulatory bodies. Assure that the area will be in a state of readiness for pre-approval inspections from regulatory bodies. Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly. Must perform all other duties and responsibilities as determined by supervision/management. QUALIFICATIONS:   B.S. Degree, Engineering preferred. Experience: 5-7 years manufacturing experience. Minimum of 2 years manufacturing supervisor experience. Aseptic processing experience preferred. Statistical analysis experience preferred. Computer skills required. Good interpersonal skills. Good analytical, technical writing, and problem solving skills. Must be willing and able to travel both domestically and internationally. Must be willing to work flexible hours to achieve desired results. 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.