Research Associate Ii, Sterility Assurance
5 months ago
**This is where you save and sustain lives**
At 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 every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
The Sterility Assurance RA II will be required to have the knowledge will be required to provide support in following;
Good understanding of the microbiology principles around sterilization and method validations required for the microbiological techniques related to Sterility Assurance. Planning, execution and documentation of microbiology method development and method validation related to sterility, BET, Bioburden and other techniques related to sterility assurance. Assessment of Aseptic process. Planning, execution, and documentation of sterilization cycle development for Moist heat sterilization (Radiation sterilization/ Gas Sterilization will be an additional skill) Good understanding of Life Cycle of sterilization development + Assess results+ Verify if anything goes wrong in the process. Good Leadership skills, team orientation and understanding of organizational cultural attributes.
**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.
- 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 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 mínimal assistance using both written and verbal methods
**Qualifications**
- Master’s degree in a scientific discipline (Microbiology/Technology/ Science) with minimum 6 years experience in microbiology testing/validation/Terminal sterilization or equivalent.
- Prefer experience with Sterilization Validation Microbiology methods validation, Global sterilization regulations & TQM methods (e.g. "six sigma")
- 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 in Microbiology techniques.
- Hands on experience cycle design and development and performing the terminal sterilization studies 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, resour
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