Principal Eng, Sterility Assurance

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.

Vantive: A New Company Built on Our Legacy

Since last year, we have been on a journey to separate our 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.

**Job Summary**

Job Title - Principal Engineer, Sterility Assurance

Location - Whitefield, Bangalore

The incumbent will be required to have the knowledge & will be required to provide support in following.

Devises new approaches to complex problems through adaptations and modifications of standard technical principles, ability to prioritize multiple tasks. Supervises/coordinates an engineer and/or technicians on assigned work. Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & topics related to Sterility Assurance. Design, development &Technical Understanding of Validation & Sterilization Engineering principles for devices/ Solutions. Planning, execution, and documentation of sterilization cycle development for Moist heat sterilization. Ethylene Oxide sterilization, Radiation sterilization Good understanding of Life Cycle of sterilization development, Assessment of result & to verify if anything goes wrong in the process. Strong Leadership skills, team orientation and understanding of organizational cultural attributes.
- Quality Assurance, Validation. Should have a good knowledge of Regulations and GMP working environment. Exposure to multiple products life cycle desirable.

**Essential Duties and Responsibilities**
- Demonstrated competency in one or more sterilization technologies including moist heat, radiation or ethylene oxide and aseptic processing.
- Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
- Ability to convince management on courses of action with mínimal assistance using both written and verbal methods.
- Effectively operate in and may facilitate cross-functional teams with guidance.
- Must be able to provide solutions that reflect understanding business objectives and cost implications.
- Contribute to technical feasibility analysis of complex research and design concepts for the sterility assurance and related controls for the products.
- Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and cycle-time.
- Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies in support of medical device, Solutions & pharmaceutical projects.
- Utilize analytical process tools to solve complex process problems (e.g., FMEA, Risk Analysis, Process Modeling, Design of Experiments). Lead small project teams as needed to accomplish project objectives.
- Study and recommend techniques to improve existing products/processes and process controls.
- Provide sterilization support for R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals
- Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP).
- Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction.
- Demonstrate working knowledge of basic technical theories and principles within the area of expertise for routine tasks.
- Devise new approaches to complex pro