Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Post : Sr Eng,Sterility Assurance
Job Description :
Summary :
• 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 will be required to provide support in following;
• Good understanding of the Science & microbiology principles, guidance, 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 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 / 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
• 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 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.
Additional Information
Qualification : Master’s degree (Microbiology / Technology / Science / Pharmacy)
Experience : 5+ years
Location : Bengaluru, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th August, 2022
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