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Process Engineer II
4 months ago
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Essential Duties and Responsibilities:
Manage projects / Product Change and Enhancement Liaise with stakeholders on requirements, technical specifications, deadlines, work schedules, feasibility, implementation and validation. Lead product design change project that affects product performance. Lead change control process, specification change and validation activities. To improve the capability of the manufacturing processes with higher predictability and lower production cost. Identify productivity improvement opportunities, recommend changes to machine parts designs, conduct feasibility studies and liaise with the stake holder on the implementation. Effective use of Lean tools to improve overall machine performance (eg, OEE). Implement Energy / Water conservation projects. Ensure process is stable and capable to meet all product requirements and ensure a safe working environment. Ensure machine make parts are of acceptable quality, safe to operate and friendly to the environment. Conduct validation studies and process investigations. Support manufacturing and maintenance engineering. Analyze machine and/ or process issue related to customer complaint and implement effective corrective and preventive action. May include leading a group of technicians to support manufacturing activities. Study parts life and establish PM schedule for TPM activities. Label Copy Changes Evaluate project request from countries or regions with Plant operations, quality and planning to conduct feasibility studies to determine technical specifications, validation, deadlines and implementation Work with supply chain and marketing on deadlines to implement changes and product transition to new changes. Draft label copy artworks and drawings in accordance with requirements and technical specifications. Liaise with procurement / vendors on requirements and verifications of product samples. Interact with Regulatory Affairs & Marketing on latest developments in regional requirement in respective countries and implementing those changes to meet requirements. Responsible for compliance to EHS procedure and requirement. For Gamma operation only: To be appointed as site Radiation Safety Officer (RSO) upon successfully completion of the required training including enforcing radiation safety in the plant. Supervise a group of Radiation Workers (Technician / GSP) to perform the Gamma Sterilization of products and sub-assemblies. Liaise with customers (BD) on gamma irradiation services requirement.Qualifications/ Education:
Degree in Mechanical/Mechantronic Engineering or equivalentSkill Set and/or Experience:
Degree with Min 3 years of relevant experience 2-3 years experience in engineering projects management and coordination Good engineering background in industrial automation, electrical and controls engineering Experience in new manufacturing machinery commissioning, debugging and validation Familiarize with basic GMP and other relevant requirements for medical/ pharmaceutical products manufacturing Knowledge of Installation Qualification(IQ)/Operational Qualification(OQ)/Performance Qualification (PQ) would be an added advantage Knowledge of PLC would be an added advantage