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Sterility Assurance Scientist M/w
il y a 1 semaine
**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.
**Summary**
Are you interested in working on exciting and unique projects? Working at Baxter is not just a job.
Join the team of highly skilled R&D professionals working in Clinical Nutrition. Working closely with the Sterility Assurance Manager, you provide Sterility Assurance leadership on multi-disciplinary teams. You support innovative design solutions and develop strategy to succeed. Contribute to technical feasibility analysis of complex research and design concepts, evaluate product requirements.
By working in our team, you will have the opportunity to learn and grow within strong community of practices.
**Responsibilities and duties**
- Make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
- Employ appropriate techniques/methods to execute routine assignments successfully and independently within negotiated deadlines. Identify existing alternative methods and technologies for improving existing or new products/processes.
- Maintain knowledge of relevant Quality System Regulations and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
- Recommend appropriate designs, techniques, and processes for a specified sequence of tasks where needed.
- Contribute to technical feasibility analysis of complex research and design concepts.
- Monitor budgets and/or activity schedules of limited scope.
- In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, can provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.**Assigned Job Functions**
- Participate on cross-functional product development teams for sterilization projects.
- Manage product development projects as the Sterility Assurance Focal Point.
- Write rationale statements for product testing/processing and sterilization projects.
- Provide validation support for Baxter manufacturing facilities.
- Write, execute, and review validation and qualification protocols and reports.
- Plan, design and execute microbiological experiments.
- Evaluate and interpret technical data and test results
- Enthusiastically embraces professional growth opportunities.
- Agile, be able to jump into a challenge and team up to work collaboratively with others across business to find solutions.
- Takes accountability for own behavior and adjusts appropriately.
- Steps outside of the 'comfort zone' - Demonstrates a pro-active attitude.
- Shows critical thinking for process improvements.
- Contributes through demonstrated hands-on participation within the teams.
- Responsible and solution driven.
**Education and/or Experience**
- Education level: Master Sciences or Ph.D.
- Scientific background: Life Sciences - Microbiology, Biochemistry, Molecular Biology, Biology.
- Experience/Expertise: 2-4 years QC/QA microbiology, Sterility assurance in pharma or medical device industry, moist heat & irradiation sterilization technology.
**Our Offer**
We offer you an international and interdisciplinary work environment
We offer you a competitive salary and benefit package.
BAXTER also supports a flexible work-life integration (hybrid working, flexi-time schedules,...).
Your office will be based in Braine L’Alleud, Belgium.
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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