Microbiology Research Jobs Baxter – Applications Invited
Research Associate II, Sterility Assurance
Job Posting at Baxter – Apply Online
Baxter is a global healthcare company dedicated to saving and sustaining lives. Our products and therapies are used in hospitals, clinics, and homes around the world. With over 85 years of experience, we have consistently pioneered medical innovations that transform healthcare and improve patient outcomes.
We believe in creating a work environment where individuals are happy, successful, and inspire each other. Join us at Baxter, where your work has a purpose and accelerates our mission of saving and sustaining lives.
Location: Ahmedabad, Gujarat, India
Job Category: Research and Development
Date Posted: 11/17/2023
Job Description
This position is primarily responsible for the planning, designing, execution, documentation, data analysis, and final report generation for Microbiology method development/method validation, sterilization cycle development, process qualification, and Sterility Assurance studies for devices, drugs, and solutions. The candidate should have a strong background in Microbiology and a strong understanding of the microbiology aspects related to sterilization and Sterility Assurance.
Qualifications
- Master’s degree in a scientific discipline (Microbiology/Technology/ Science) with minimum 6 years of 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”)
- Display a solid technical understanding of Microbiology and Sterilization Engineering principles and qualification practices & application of these principles on individual/small projects.
- Technical writing skills, remote support for projects, strong interpersonal skills and with a quick adaptive mindset for the new technologies.
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 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
Skills
- 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 in Microbiology techniques.
- Hands-on experience cycle design and development and performing the terminal sterilization studies with the 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.
How to Apply
Please apply online through the following link: Apply Online
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