Process Engineer II

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. 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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Essential Duties and Responsibilities: 1. Manage projects / Product or Process Change and Enhancement a) Liaise with stake holders on requirements, technical specifications, deadlines, work schedules, feasibility, implementation and validation. b) Assist in product design change project that affects product performance. c) Lead change control process, specification change and validation activities. 2. To improve the capability of the manufacturing processes with higher predictability and lower production costs. a) Identify productivity improvement opportunities, recommend changes to machine parts designs, conduct feasibility studies and liaise with the stake holder on the implementation. b) Effective use of Lean tools to improve overall machine performance (eg, OEE). c) Implement Energy / Water conservation projects. d) Ensure process is stable and capable of meeting all product requirements while maintaining a safe working environment. Verify that machine-produced parts are of acceptable quality, safe to operate and environmentally friendly. Conduct validation studies and process investigations. 3. Support manufacturing and maintenance engineering. 4. Analyze machine and/ or process issue related to customer complaint and implement effective corrective and preventive action. a) May include leading a group of technicians to support manufacturing activities. Study parts life and establish PM schedule for TPM activities. 5. Label Change a. 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. b. Work with supply chain and marketing on deadlines to implement changes and product transition to new changes. c. Draft label copy artworks and drawings in accordance with requirements and technical specifications. d. Liaise with procurement / vendors on requirements and verifications of product samples. e. Interact with Regulatory Affairs & Marketing on latest developments in regional requirement in respective countries and implementing those changes to meet requirements. 6. Responsible for compliance to EHS procedure and requirement. Qualifications/ Education: • Degree in Mechanical/Mechantronic Engineering or equivalent Skill Set and/or Experience: • Degree with Min 3 years • 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. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.