Engineer II, Sterility Assurance

1 week 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 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.

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