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.

Job Summary

Job Title – Principal Engineer, Sterility Assurance (Devices)

Location – R&D Whitefield, Bangalore

Global subject matter expert for Sterilization with the ability to represent Vantive on topics related to Device Sterilization for management discussions and discussions with Regulatory Agencies. Schedules and leads through the planning and execution of projects or defined piece of a larger project for sterilization cycle development, process qualification and Sterility Assurance studies for devices, drugs, and or Solutions. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups. 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 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 focusing on sterilization with radiation and gases / Solutions.

• Strong foundation on Alternative methods of sterilization & Novel Sterilization and the new developments around sterilization.       

• Planning, execution, and documentation of sterilization cycle development for Radiation sterilization ,. Ethylene Oxide sterilization, Moist heat 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. Ability to lead as a Global subject matter expert for Device sterilization. Ability to facing Regulatory audits and coordinate & collaborate at Global levels with different regulatory bodies and agencies.

• Ability to represent Vantive Sterility Assurance in Industry forums.

• Strong understanding of guidance related to device Sterilization and passion to make a difference to the future of the Industry.

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  Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)- 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 of sterilization technologies including Radiation Sterilization and ethylene oxide/ Sterilization with gases 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 minimal 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.

  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 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 (Microbiology/Technology/ Science/ Pharmacy) with minimum 8 years or BS with minimum 10 years’ experience in sterilization validation or equivalent.

  Prefer experience with Sterilization Validation / Microbiology methods validation, Global sterilization regulations & TQM methods (e.g., "six sigma")

  Display a solid technical understanding of Sterilization Engineering principles and qualification practices & 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, and writing study rationale documents.

  ·       Technical writing skills, remote support for projects, strong interpersonal skills and 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

  Vantive’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific

  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.

  Equal Employment Opportunity

  Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion,

  gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other

  legally protected characteristics.       

   

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

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