Quality Engineer II - Validation

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter

As a Quality Assurance Validation & Data Integrity Specialist, you will serve as an independent quality partner responsible for providing oversight and guidance across validation, qualification, and data integrity activities. You will help ensure regulatory compliance throughout the lifecycle of equipment, facilities, utilities, manufacturing processes, cleaning programs, and computerized systems.

In this role, you will collaborate with cross-functional stakeholders to assess risk, review critical documentation, support inspection readiness, and verify that quality systems remain effective and compliant. Your work will influence operational excellence, regulatory readiness, and the consistent delivery of products that improve and save lives.

What You'll Be Doing

• Provide quality assurance leadership for validation and qualification projects by partnering with stakeholders from initial risk assessment through final approval and project closure.
• Review and approve validation, qualification, and lifecycle documentation to ensure compliance with cGMP requirements, quality standards, and regulatory expectations.
• Evaluate change controls, validation impact assessments, periodic reviews, and revalidation strategies to support risk-based and compliant decision-making.
• Assess and approve quality-related electronic quality management system (eQMS) records while ensuring clear accountability with process, engineering, laboratory, and system owners.
• Lead data integrity assessments and compliance reviews, identify opportunities for improvement, verify corrective actions, and strengthen sustainable controls.
• Analyze trends in validation deviations, data integrity observations, and quality system metrics to proactively identify risks and recommend appropriate escalation.
• Support regulatory inspections and audits by providing subject matter expertise, preparing inspection-ready documentation, and coaching cross-functional teams on validation and data integrity expectation

What You'll Bring

Required Qualifications

• Bachelor's degree in Engineering, Science, Computer Science, or a related technical discipline.
• 3+ years of experience in Quality Assurance, Validation, Quality Engineering, Computerized Systems Validation, Data Integrity, Laboratory Systems, or a related role within a cGMP-regulated industry.
• Working knowledge of cGMP regulations, GAMP 5 principles, 21 CFR Part 11 requirements, ALCOA+ data integrity principles, and risk-based quality management practices.
• Experience independently reviewing validation protocols, qualification documents, reports, deviations, change controls, and compliance assessments.
• Strong analytical, technical, and problem-solving skills with the ability to evaluate risk and make sound quality decisions.
• Ability to influence and collaborate effectively across multiple functions while maintaining independent quality oversight and judgment.
• Strong written and verbal communication skills with the ability to clearly communicate compliance risks and recommendations to stakeholders and leadership.

Preferred Qualifications

• Experience supporting regulated computerized systems and computerized system lifecycle activities.
• Familiarity with eQMS platforms, audit trail review programs, electronic records controls, and validation management processes.
• Experience supporting regulatory inspections, audits, or inspection readiness activities.
• Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), or similar credentials.
• Demonstrated experience coaching colleagues or leading quality-related continuous improvement initiatives.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 - $121,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. …