Quality Engineer II - Validation

Baxter • Round Lake, IL

1d

About The Position

As a Quality Assurance Validation & Data Integrity Specialist, this role serves as an independent quality partner providing oversight and guidance across validation, qualification, and data integrity activities. The position helps ensure regulatory compliance throughout the lifecycle of equipment, facilities, utilities, manufacturing processes, cleaning programs, and computerized systems.

The role collaborates with cross-functional stakeholders to assess risk, review critical documentation, support inspection readiness, and verify that quality systems remain effective and compliant. Its work supports operational excellence, regulatory readiness, and the consistent delivery of products that improve and save lives.

Requirements

• Bachelor's degree in Engineering, Science, Computer Science, or a related technical discipline.
• At least 3 years of experience in Quality Assurance, Validation, Quality Engineering, Computerized Systems Validation, Data Integrity, Laboratory Systems, or a related role in 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, including the ability to evaluate risk and make sound quality decisions.
• Ability to influence and collaborate effectively across functions while maintaining independent quality oversight and judgment.
• Strong written and verbal communication skills, including the ability to clearly communicate compliance risks and recommendations to stakeholders and leadership.
• Authorization to work for any employer in the United States; visa sponsorship is not available.

Nice To Haves

• 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 certification 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.

Responsibilities

• Provide quality assurance leadership for validation and qualification projects, partnering with stakeholders from initial risk assessment through final approval and project closure.
• Review and approve validation, qualification, and lifecycle documentation for compliance with cGMP requirements, quality standards, and regulatory expectations.
• Evaluate change controls, validation impact assessments, periodic reviews, and revalidation strategies to support risk-based, compliant decisions.
• Assess and approve quality-related eQMS records while ensuring clear accountability with process, engineering, laboratory, and system owners.
• Lead data integrity assessments and compliance reviews, identify improvement opportunities, verify corrective actions, and strengthen sustainable controls.
• Analyze trends in validation deviations, data integrity observations, and quality system metrics to identify risks and recommend 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 expectations.

Benefits

• Medical and dental coverage starting on day one.
• Basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan with employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence and paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program.
• Childcare benefits.
• May be eligible for discretionary bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level