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.

We are seeking an R&D Project Lead in Sterility Assurance to join our elite research team in Braine L'Alleud, where you will play a crucial role in ensuring flawless sterility across our product lines

#This is where your dedication drives success!

This position offers a unique opportunity to lead multi-disciplinary teams and apply your expertise in sterility assurance to drive innovation and excellence. You will develop design strategies and research projects, address complex technical requirements, and contribute to Baxter's vision of providing outstanding healthcare solutions.

Essential Duties and Responsibilities

• Independently complete 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 innovative approaches to sophisticated 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 field. Routinely provide advice and assistance to team members regarding unique problems.

• 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 related deliverables.

• Act as the Sterility Assurance Project Lead or Focal Point for Baxter projects.

• Coordinate with minimal guidance Sterility Assurance activities for teams with broad scopes.

• Provide input for schedules, budgets, product requirements, product design, and regulatory submissions.

• Attend project meetings.

• Develop validation plans (i.e. Rationale Statement) and sterilization parameters.

• Lead and support product development studies.

• Serve as a liaison with manufacturing facilities.

• Communicate program status with multi-disciplinary project teams and Sterility Assurance management.

• Support regulatory submissions.

• Provide technical support to multi-disciplinary 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.

Qualifications

• B.S. in engineering with 5-8 years related experience, or M.S. in engineering with 2-4 years experience, or Ph.D. with 1-2 years experience.

• Demonstrates a proven understanding of theories/practices applied by other fields beyond the 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 information that engages the audience.

• Apply a logical, methodical approach to independently solve problems, develop solutions, and make recommendations.

• Ability to make decisions when provided with limited information and to make routine decisions independently.

• Contribute to efforts beyond own scope of responsibilities to ensure project achievements are met.

• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.

• Ability to optimally mentor junior level associates.

• Ability to design experiments and draw significant conclusions from experimental data.

• Knowledge of sterilization modalities (Moist Heat, Ethylene Oxide, Radiation, Aseptic Processing) preferred.

• GMP experience desired and knowledge of regulatory requirements for sterile products preferred.

• Ability to provide solutions that reflect understanding of business objectives and cost implications.

• Ability to travel 20% of time.

What are some of the benefits of working at Baxter?

We offer a competitive total compensation package, with professional development opportunities, where a high importance is placed on work-life balance!

Equal Opportunity Employer Statement: Baxter Healthcare Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Reasonable Accommodation Statement: Baxter Healthcare Corporation is committed to providing reasonable accommodations to applicants with disabilities. If you require a reasonable accommodation during the application process, please let us know.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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