Engineer II, Sterility Assurance

2 weeks ago

Bengaluru, India Baxter Full time

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.

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis;

sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy

automation, software and services. The company’s global footprint and the critical nature of its products and services

play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide

are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare

innovations that enable patient care.

Job Summary

• Job Title – Engineer II, Sterility Assurance

• Location – Whitefield, Bangalore

This position is primarily responsible for the planning, designing, execution, documentation, data analysis and final report generation for sterilization cycle development, process qualification and Sterility Assurance studies for devices, drugs and Solutions. The candidate should have a strong background of sterilization Validation and should have a strong understanding of the scientific aspects related to sterilization and Sterility Assurance.

The Sterility Assurance Engineer will be required to have the knowledge required to provide support in following.

Good understanding of the Science & Sterilization principles, guidance, regulations around sterilization validation & related to Sterility Assurance. Design, development &Technical Understanding of Validation & Sterilization Engineering principles for devices. Planning, execution, and documentation of sterilization cycle development for Ethylene Oxide sterilization, Radiation sterilization/ (Steam sterilization/ Sterilization with heat will be an additional skill) Good understanding of Life Cycle of sterilization development, Assessment of result & to verify if anything goes wrong in the process. Solid Leadership skills, team orientation and understanding of organizational cultural attributes.

Candidate working with a Device Development Company- Research and Development, Quality Assurance, Validation, Sterilization, Sterility Assurance, Regulatory but should have a good knowledge of Regulations and GMP working environment. Exposure to product life cycle, Research and Development and product delivery is strongly desirable.

Essential Duties and Responsibilities

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 devices and disposables. 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. Perform standard sterilization engineering assignments for application, validity and conformance to specifications. 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) to ensure compliance in all research, data collection and reporting activities. Develop reports and presentations on technical plans and results. 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 minimal assistance using both written and verbal methods. Knowledge around microbiological aspects of Biological indicators, Adventitious Agents and related microbiological concepts. 

Qualifications

Master’s degree in a scientific discipline (Engineering &Technology/ Science/ Pharmacy) with minimum 4 years or BS with minimum 6 years’ experience in sterilization validation or equivalent. Prefer experience with Sterilization Validation, Device/Product Development Lifecycle, Global sterilization regulations & TQM methods (e.g. "six sigma") Display a solid technical understanding of Sterilization Engineering principles and qualification practices for Device Sterilization & application of these principles on individual/small projects. The position requires technical skills for device sterilization using Gas (EO/VHP) / Radiation, assessing critical changes & impact assessments, writing study rationale documents. Technical writing skills, remote support for projects, strong interpersonal skills and with a quick adaptive mindset for the new technologies.

Skills

Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones. Proficient with Sterilization validation principles and related testing for Biological indicators etc. Hands on experience cycle design and development and performing the sterilization studies for devices with use of PCD /biological indicators. Highly adept at grasping and solving complex problems using root-cause analysis techniques. Ability to objectively identify technical solutions and make sound decisions Project management experience for Quality & value improvement projects Self-driven, resourceful, and able to work on multiple projects and priorities. Strong organization, attention to detail, and documentation skills. Strong acquaintance with technology, QMS tools and collaboration tools over the web: e.g. Trackwise, Document tools, WebEx, Teams, Microsoft Office products, etc.

A Career That Matters

innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and

technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing

creative collaborations that bring our mission to life for patients every day.

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