Principal Engineer, Ops Metrology & Qualification

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:

You will play a crucial role in ensuring our analytical instruments operate flawlessly, contributing to our mission of delivering outstanding healthcare solutions.

What you will do:

• Perform validation of a wide range of analytical instruments, from simple to complex, ensuring full compliance with regulatory requirements, including FDA and EU standards.

• Build comprehensive validation packages, author critical documents, review them meticulously, and conduct thorough testing to ensure regulatory compliance.

• Participate in the selection, acquisition, and successful implementation of new laboratory analytical instruments on site.

• Apply your proven expertise to troubleshoot instrument failures, ensuring timely availability and functionality for internal customers.

• Schedule and manage periodic calibrations and preventive maintenance of analytical instruments to maintain their efficient performance.

• Collaborate closely with QA and subject matter experts to implement new mentorship programs and norms in assigned procedures, and develop new procedures when necessary.

• Act as a Subject Matter Expert (SME) for complex validation projects, supporting and mentoring junior team members while managing multiple validation projects simultaneously.

• Provide in-depth expertise in Empower application and related chromatography systems (HPLC, UPLC, GC).

• Stay updated on pharmacopeia changes and updates related to analytical instruments, and act as an SME for audit-related inquiries.

• Actively participate in audit preparation, control room activities, and respond to auditors' questions during audits.

• Represent the Metrology & Qualification department in Site Quality Reviews (SQR) and CAPA Review Board (CRB) meetings.

What you will bring:

• Strong knowledge of GMP/GDP in the pharmaceutical industry.

• Proven skills in analytical instrument validation, including data integrity and computer system validation.

• Familiarity with a variety of analytical instruments.

• Outstanding organizational skills with the ability to manage multiple pieces of equipment simultaneously.

• Ability to work effectively in a team environment, demonstrating strong collaboration and interpersonal skills.

• Certified in data integrity (Eudralex Annex 11 & FDA 21 CFR part 11).

• Education: Master’s degree or equivalent experience in chemical engineering, pharmaceutical industry, or a related field.

• Language: Professional proficiency in English.

• Experience: At least 4 years of experience in validation, calibration, and maintenance of analytical instruments.

What are some of the benefits of working at Baxter?

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

Baxter Healthcare Corporation is an equal opportunity employer. We celebrate diversity and are committed to fostering 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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