Senior Engineer, Sterility Assurance- Solutions

Vantive; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Vantive in Whitefield, Bangalore is seeking a Senior Engineer, Sterility Assurance- Solutions to lead sterilization cycle development, validation studies, and related regulatory activities for devices, drugs, and solutions. You will plan, execute, and document Sterility Assurance studies with cross-functional teams.

The role requires a Master’s in a scientific discipline and 14+ years’ experience in sterilization validation (EO/VHP, moist heat, or radiation), with strong regulatory knowledge and

Qualifications

• Master’s degree in Microbiology/Technology/Science/Pharmacy or equivalent with extensive experience in sterilization validation.
• Experience with sterilization validation methods (EO/VHP, radiation, moist heat) and related regulatory controls.
• Strong technical writing, remote support for projects and risk assessment skills.
• Knowledge of GMP, GDP and global sterilization regulations.

Responsibilities

• Lead sterilization cycle development and validation studies for devices, solutions, and pharma projects.
• Plan, execute, and document Sterility Assurance activities and related studies.
• Coordinate cross-functional teams and manage project timelines and resource allocation.
• Provide troubleshooting support and technical guidance to R&D and manufacturing.

Skills

Sterility Validation

Sterilization Technologies

Quality Assurance

Regulatory Compliance

Project Management

Leadership

Education

Master’s degree in a scientific discipline

BS with 14+ years’ experience in sterilization validation

Job description

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 – Senior Engineer, Sterility Assurance- Solutions

Location – Whitefield, Bangalore

With minimal guidance, schedules and leads through the planning and execution of a smaller project or defined piece of a larger project for sterilization cycle development, process qualification and Sterility Assurance studies for devices, drugs, and 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.

a) 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.

b) Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & topics related to Sterility Assurance.

c) Design, development & Technical Understanding of Validation & Sterilization Engineering principles for devices/ Solutions.

d) Planning, execution, and documentation of sterilization cycle development for Moist heat sterilization. Ethylene Oxide sterilization, Radiation sterilization

e) Good understanding of Life Cycle of sterilization development, Assessment of result & to verify if anything goes wrong in the process.

f) Strong Leadership skills, team orientation and understanding of organizational cultural attributes.

g) Strong technical Knowledge on the working principles of the Sterilizer and the Sterile Manufacturing facilities processing lines.

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 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 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 the 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 10 years or BS with minimum 14 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, 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.

Reasonable Accommodation

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