Baxter Job Opening For BSc & MSc Candidates, Apply Online
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Job Name – Sr Eng, Sterility Assurance
Req # – JR – 075228
Location – Bengaluru, Karnataka, India
Job Category – Research and Development
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 in 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 will be required to provide support in the following;
Good understanding of the Science & microbiology principles, guidance, and regulations around sterilization validation & related to Sterility Assurance. Design, development &Technical Understanding of Validation & Sterilization Engineering principles for devices/ Solutions. Planning, execution, and documentation of sterilization cycle development for Steam Sterilization/ Ethylene Oxide sterilization, Radiation sterilization Good understanding of Life Cycle of sterilizationdevelopment, 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 / Drug Company (Device preferred but would consider Pharma/ Biopharma)- Quality Assurance, Validation. Should have a good knowledge of Regulations and the GMP working environment. Exposure to multiple product life cycles is desirable.
Essential Duties and Responsibilities
- Contribute to technical feasibility analysis of complex research and design concepts including a lot of microbiology inputs 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 devices, 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 troubleshooting & 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 the primary area of expertise.
- Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
- Knowledge of microbiological aspects of Biological indicators, Adventitious Agents and related microbiological concepts.
- Master’s degree in a scientific discipline (Microbiology/Technology/ Science/ Pharmacy) with a minimum of 6 years or BS with a minimum of 8 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.
- Excellent English verbal and written communication skills, skilled to coordinate with global stakeholders and support across 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 the 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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