Quality Engineer II - Validation

Baxter; Round Lake Beach (IL); Presencial; USD 88.000 - 121.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical and dental coverage

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Descripción de la vacante

At Baxter, a Quality Assurance Validation & Data Integrity Specialist serves as an independent quality partner overseeing validation, qualification, and data integrity activities. You will help ensure regulatory compliance across equipment, facilities, utilities, manufacturing processes, cleaning programs, and computerized systems.

You will collaborate with cross-functional stakeholders to assess risk, review critical documentation, support inspection readiness, and verify that quality systems

Formación

• Bachelor’s degree in a technical discipline and 3+ years in QA/validation in a cGMP environment.
• Solid knowledge of cGMP, GAMP 5, 21 CFR Part 11, ALCOA+ data integrity.
• Experience reviewing validation protocols, reports, deviations, and change controls.
• Strong analytical, communication, and cross-functional collaboration skills.

Responsabilidades

• 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

Conocimientos

Analytical thinking

Cross-functional collaboration

Regulatory knowledge

Communication skills

Educación

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

Herramientas

eQMS platforms

Audit trail review

Electronic records controls

Validation management

Descripción del empleo

This is whereyour 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

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. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

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.

Recruitment Fraud Notice

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