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R&D Project Lead - Sterility Assurance

Req #: JR - 034675 Location Braine-l'Alleud, Wallonia, Belgium Job Category: Research and Development Date Posted: 04/06/2021

Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Courage
  • Action Oriented
  • Collaborates
  • Cultivates Innovation
  • Manages Ambiguity
  • Drives Results

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R&D Project Lead - Sterility Assurance

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

  • Provide Sterility Assurance leadership on multi-disciplinary teams.
  • Displays standard engineering principles to resolve difficult problems, from conception to final design with team input.
  • Develops design strategies or research projects, which are non-routine within areas of expertise to address specific technical requirements of a project.
  • Displays a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise

Essential Duties and Responsibilities

  • 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.
  • Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality and cycle-time.
  • Contribute to technical feasibility analysis of complex research and design concepts.
  • 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.
  • Develop an in-depth knowledge and understanding of GxP and related regulations and guidance.
  • May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems.
  • Provide Sterility Assurance leadership on multi-disciplinary teams.
  • Contribute to the maintenance of Baxter's leadership position for sterility assurance within the healthcare industry. Provide guidance and interpretation of local, regional and global regulations.
  • Support product development efforts through the management and execution of the sterility assurance related deliverables.
  • Act as the Sterility Assurance Project Lead or Focal Point for Baxter top projects, GBU projects or manufacturing facility VIPs, change controls and SNCs. Responsibilities include the following:
  • Coordinate with minimal guidance Sterility Assurance activities for product development teams with broad scopes
  • Provide input for schedules, budget and product requirements
  • Provide input for product design
  • Provide support for regulatory submissions
  • Attend project meetings
  • Develop validation plan (i.e. Rationale Statement)
  • Develop sterilization parameters for product development
  • Leads and supports product development studies
  • Liaison with manufacturing facility
  • Communicate program status with multi-disciplinary project team and Sterility Assurance management
  • Support regulatory submissions
  • Provide technical support to multi-disciplinary product development teams, domestic and international manufacturing facilities, Regulatory Affairs and internal Sterility Assurance customers.
  • Provide support for complex investigations, trouble-shooting, and CAPAs. 
  • Evaluate results relative to product requirements, definitions and/or program goals.
  • Ability to prioritize multiple tasks.

Qualifications

  • B.S. engineering and 5 - 8 years related experience, or M.S. engineering and 2- 4 years related experience, or Ph.D. 1 - 2 years experience.
  • Proficient in the English language (written and oral)
  • Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
  • Displays a strong understanding of engineering concepts in support of the appropriate areas of technical expertise.
  • 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 and ability to make routine decisions independently.
  • Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Ability to effectively mentor junior level associates.
  • Ability to design experiments and draw meaningful conclusions from experimental data.
  • Knowledge of sterilization modalities (Moist Heat, Ethylene Oxide, Radiation, Aseptic Processing) preferred.
  • Knowledge of regulatory requirements for sterile products (Moist Heat, Ethylene Oxide, Radiation, Aseptic Processing) preferred.
  • GMP experience desired.
  • Effectively operate in and may facilitate multi-disciplinary teams.
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.

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 [email protected] and let us know the nature of your request along with your contact information.

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

"For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."

Reagan

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

"I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world."

Karthik

Meet Amitha, Research Associate in India

"Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter."

Amitha

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Reagan

Meet Reagan, Senior Research Scientist in the United States

"For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."

Karthik

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

"I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world."

Amitha

Meet Amitha, Research Associate in India

"Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter."

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