Eng Ii, 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 - Engineer II- Lab, Sterility Assurance & Microbial Sciences**:

- **Location - Whitefield, Bangalore**:

- **Shift - General**

**Responsibilities**:

- Microbiology & Quality Assurance/Control. Should have a good knowledge of Regulations and GMP working environment. Exposure to multiple products life cycle desirable.
- Contribute to technical feasibility analysis of complex research and design concepts including a lot of microbiology inputs for Sterility Assurance and related controls for the products.
- Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & related to Sterility Assurance.
- Design, development & Technical Understanding of Microbial Method Validation & Sterilization Engineering principles for devices/ Solutions.
- Support Lab Manager by assuring contract laboratories documentation and internal lab documentation are audit ready and team can effectively respond to auditor inquiries.
- Work with Quality team to ensure adequate documentation, input into computer systems, and being the point person for addressing quality issues.
- Operation of steam sterilizer as per set procedure for various Sterility Assurance studies (Class-C & B studies).
- Prioritization of sterilizer cycles as per project need and urgency ensuring timely completion of project deliverables.
- To document all the sterilization study records manually or by using ELN templates.
- To learn and develop expertise in execution of different CCI methods (Air Under Water & Gurley).
- Responsible for calibration and maintenance of all laboratory equipment.
- Responsible for maintaining optimum inventory of lab consumables.
- Responsible for maintaining anytime audit readiness of Sterilization lab.
- Design and draft various study protocols as per project need.
- Equipment procurement and assure necessary validations and documentation.
- Support Lab Manager to maintain lab operations.
- Provide regular/timely updates to Sterility Assurance Management.
- Assure all work complies with Vantive’s QMS and cGDP/cGMP/cGLP practices.
- 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 Renal 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 area of expertise for routine tasks.
- Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles.
- Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety)