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Summary
This position will consist of managing sterilization processes before products are released as well as managing changes to products on the market. This role would be best fit for a Microbiologist that possesses sterility assurance/science experience as well as project management skills. The position may require up to 20% travel, but mainly supports global manufacturing facilities from Baxter's Round Lake, IL location.
Essential Duties and Responsibilities
- Contribute to technical feasibility analysis of complex research and design concepts.
- Evaluate results relative to product requirements, definitions and/or program goals.
- Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality and cycle-time.
- May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems.
- Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
- Maintain current knowledge of relevant QSRs 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 budgets and activity schedules of limited scope. In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to 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.
- Independently plan and execute a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
- Participate on cross-functional product development teams for aseptic and terminal sterilization projects.
- Manage product development projects as the Sterility Assurance Focal Point.
- Write rationale statements for aseptic and terminal 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.
- Develop project plans and costs.
Qualifications
- Bachelors degree in a scientific discipline with at least 5-7 years experience or at least 3-5 years relevant experience with Masters and 0-3 years experience with PhD.
- The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills.
- Research lab experience may include research in GMP/QSR environment, cross-functional teamwork, and independent experimentation in method development and validation.
- Ability to organize and communicate complex information that engages the audience.
- Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations.
- Ability to make decisions when provided with limited information.
- Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
- Ability to make routine decisions independently.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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