Senior Engineer, Sterility Assurance, Solutions

1 week ago

Bengaluru, Karnataka, India Scalene works Full time

Job Title – Senior Engineer, Sterility Assurance, Solutions
• Location – Whitefield, Bangalore
• Shift – General 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 Solutions, drugs and devices. 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 the following.


• Good understanding of the Science & Sterilization principles, guidance, regulations around sterilization validation & related to Sterility Assurance for Solutions. Design, development &Technical Understanding of Validation & Sterilization Engineering principles for Solutions and or devices.


• Planning, execution, and documentation of sterilization cycle development for Moist Heat Sterilization, (Knowledge of Ethylene Oxide sterilization, Radiation sterilization 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 microbiology inputs for sterility assurance and related controls for the Solutions and devices/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) with minimum 6 years or BS with minimum 8 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 Solution Sterilization & application of these principles on individual/small projects.


• The position requires technical skills for Solution sterilization using Moist heat (Steam), 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 solutions with use of 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.

  • Senior Engineer, Sterility Assurance, Solutions

    1 week ago

    Bengaluru, Karnataka, India Scalene works Full time

    Job Title – Senior Engineer, Sterility Assurance, Solutions Location – Whitefield, Bangalore Shift – General 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 Solutions,...

  • Senior Engineer Sterility Assurance Solutions

    2 weeks ago

    Bengaluru, Karnataka, India Scalene works Full time

    Job Title Senior Engineer SterilityAssurance Solutions Location Whitefield Bangalore Shift GeneralThis position is primarily responsible for the planning designingexecution documentation data analysis and final report generationfor sterilization cycle development process qualification andSterility Assurance studies for Solutions drugs and devices....

  • Engineer II, Sterility Assurance

    2 weeks ago

    Bengaluru, Karnataka, India Scalene works Full time

    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...

  • Engineer II, Sterility Assurance

    2 weeks ago

    Bengaluru, Karnataka, 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...

  • Research Associate Ii- Sterility Assurance

    1 week ago

    Bengaluru, Karnataka, India BAXTER Full time

    This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...

  • Principal Engineer

    1 week ago

    Bengaluru, Karnataka, India Baxter Full time

    Vantive: A New Company Under Our Long HistoryBaxter is going through a process to turn our Kidney Care segment of around $5B into a new independent company. Vantive* will leverage our almost 70-year heritage in acute therapies and dialysis to offer top-notch care to our patients. We are confident that Vantive will not only strengthen our position in the...

  • Senior Mechanical Engineer

    1 week ago

    Bengaluru, Karnataka, India Abha Engineer Full time

    We are looking for a Senior Mechanical EngineerRoles are described below.Manpower Planning.Preparing of Project Cost.Schedule wise work execution.As Drawing & quality work execution.Client & Third Party Manage.Working Team Manage & Review.Reporting to Management.ROB & FOB Fabrication & Erection Work Knowledge.

  • Senior Quality Engineer – Microbiology

    2 weeks ago

    Bengaluru, Karnataka, India ALTEN India Full time

    JOB DESCRIPTION:Essential duties & responsibilities: Possess knowledge of a variety of microbiological concepts, practices, and procedures related toFDA guidelines, EU guidelines, ISO17664, ISO 17665, AAMI ST79, ANSI/AAMI ST98, AAMI TIR 12and ISO Manage the testing conducted by external laboratories according to procedures and standardsregarding reprocessing...

  • Senior Quality Engineer – Microbiology

    1 week ago

    Bengaluru, Karnataka, India ALTEN India Full time

    JOB DESCRIPTION:Essential duties & responsibilities:Possess knowledge of a variety of microbiological concepts, practices, and procedures related toFDA guidelines, EU guidelines, ISO17664, ISO 17665, AAMI ST79, ANSI/AAMI ST98, AAMI TIR 12and ISO 10993. Manage the testing conducted by external laboratories according to procedures and standardsregarding...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bengaluru, Karnataka, India Shell Recharge Full time

    Shell Recharge Solutions is a leader in delivering the new electric mobility future through innovative software, infrastructure, and professional services that empower utilities, cities, fleets, transit agencies, and automakers to deploy EV charging infrastructure at scale. Our technology is connecting EV infrastructure solutions with public and private...

  • Senior Quality Assurance Engineer

    1 week ago

    Bengaluru, Karnataka, India Xindus Trade Networks Pvt. Ltd. Full time

    Overview : We are seeking an experienced and proactive Senior Quality Assurance (QA) Engineer with comprehensive expertise across leading quality initiatives. This role focuses on ensuring the quality testing, automation, performance, security and seamless integration of our backend systems developed in Java and Spring Boot, along with frontend technologies...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bengaluru, Karnataka, India Shell Recharge Full time

    Shell Recharge Solutions is a leader in delivering the new electric mobility future through innovative software, infrastructure, and professional services that empower utilities, cities, fleets, transit agencies, and automakers to deploy EV charging infrastructure at scale. Our technology is connecting EV infrastructure solutions with public and private...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bengaluru, Karnataka, India HTC Global Services Full time

    We are hiring for a Senior Quality Assurance Engineer with PUBSUB.Years of Experience - 5+ yearsLocation - Chennai/Bangalore/HyderabadNotice Period - ImmediateRequirements:Strong knowledge of software QA methodologies, tools, and processes.Experience testing projects built on Java/Python.Familiarity with pub-sub architecture and Azure OpenAI...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bengaluru, Karnataka, India HTC Global Services Full time

    We are hiring for a Senior Quality Assurance Engineer with PUBSUB.Years of Experience - 5+ yearsLocation Chennai/Bangalore/HyderabadNotice PeriodImmediateRequirements:Strong knowledge of software QA methodologies, tools, and processes.Experience testing projects built on Java/Python.Familiarity with pub-sub architecture and Azure OpenAI endpoints.Experience...

  • Senior Principal Engineer

    2 weeks ago

    Bengaluru, Karnataka, 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...

  • Quality Assurance Engineer

    1 week ago

    Bengaluru, Karnataka, India Programming Full time

    Job Title : Senior QA Engineer (Programming Focus)Location : Bangalore IndiaCompany Overview :is a leading technology company specializing in innovative solutions for IT industry. Our mission is to empower businesses with cutting-edge software products that drive growth and efficiency. We are currently seeking a highly skilled Senior QA Engineer with a...

  • Senior Quality Assurance Engineer

    1 week ago

    Bengaluru, Karnataka, India HTC Global Services Full time

    We are hiring for a Senior Quality Assurance Engineer with PUBSUB. Years of Experience - 5+ years Location - Chennai/Bangalore/Hyderabad Notice Period - Immediate Requirements: Strong knowledge of software QA methodologies, tools, and processes. Experience testing projects built on Java/Python. Familiarity with pub-sub architecture and Azure OpenAI...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bengaluru, Karnataka, India Flexera Software India LLP Full time

    We're transforming the software industry. We're Flexera. With more than 50,000 customers across the world, we're achievingthat goal.Butwe knowwe can't do any of that without our team. Ready to help us re-imagine the industry during a time of substantial growth and ambitious plans? Come and see why we're consistently recognized by Gartner, Forrester and IDC...

  • Safety Assurance Engineer

    1 week ago

    Bengaluru, Karnataka, India Alstom Full time

    Req ID: 450295Leading societies to a more sustainable future, Alstom specializes in developing and offering eco-friendly mobility solutions to shape the future of transportation. The product range includes high-speed trains, metros, monorails, trams, integrated systems, tailored services, infrastructure, signaling, and digital mobility solutions. When you...

  • Senior Solutions Engineer

    1 week ago

    Bengaluru, Karnataka, India JFrog Full time

    Senior Solutions Engineer Bangalore, India | Sales Share position At JFrog, we're reinventing DevOps to help the world's greatest companies innovate -- and we want you along for the ride. This is a special place with a unique combination of brilliance, spirit and just all-around great people. Here, if you're willing to do more, your career can take off....