Quality Assurance Validation Engineer, Data Integrity

Zvh; United States; On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

401(k) with employer match

Employee Stock Purchase Plan (ESPP)

Job summary

Baxter is seeking a Quality Assurance Validation & Data Integrity Specialist to oversee validation, qualification, and data integrity activities. You will collaborate with cross-functional teams to ensure regulatory compliance across equipment, facilities, utilities, and computerized systems, contributing to operational excellence and patient safety.

Responsibilities include risk assessment, review of critical documentation, and proactive quality oversight to support inspections and continuous

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.
• Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, ALCOA+ data integrity, and risk-based quality management practices.

Responsibilities

• Provide QA leadership for validation and qualification projects from risk assessment to final approval and closure.
• Review and approve validation, qualification, and lifecycle documentation for compliance with cGMP and regulatory expectations.
• Lead data integrity assessments, identify improvements, verify corrective actions, and strengthen controls.
• Support regulatory inspections and audits with subject matter expertise and inspection-ready documentation.

Skills

Analytical thinking

Communication skills

Problem solving

Risk assessment

Education

Bachelor's degree in Engineering, Science, Computer Science or related technical discipline

Tools

eQMS platforms

Job description

Baxter is seeking a Quality Assurance Validation & Data Integrity Specialist to oversee validation, qualification, and data integrity activities. You will collaborate with cross-functional teams to ensure regulatory compliance across equipment, facilities, utilities, and computerized systems, contributing to operational excellence and patient safety.

Responsibilities include risk assessment, review of critical documentation, and proactive quality oversight to support inspections and continuous