Qualification & Validation Subject Matter Expert (SME)

Baxter International; Round Lake (IL); On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

Health insurance

401(k) Retirement Savings Plan (ESPP)

Paid time off 20–35 days

Flexible Spending Accounts

Job summary

Baxter International is seeking a qualified Qualification & Validation Subject Matter Expert (SME) to drive commissioning, qualification, validation, and lifecycle management across sterile manufacturing operations.

You will partner with Quality, Engineering, Manufacturing, Validation, and site leadership to strengthen programs, address complex compliance challenges, and support operational excellence across multiple locations.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 15+ years in pharma manufacturing validation/engineering/quality within regulated environments.
• Experience supporting qualification/validation in GMP settings.
• Expertise in equipment, facility, utility qualification and HVAC, water systems.
• Strong understanding of validation lifecycle, data integrity, and regulatory expectations.
• Experience supporting regulatory inspections and remediation programs.
• Excellent communication and cross-functional influencing skills.
• Travel regularly to multiple locations.
• Experience in sterile manufacturing preferred.

Responsibilities

• Provide technical leadership for qualification and validation programs across manufacturing.
• Support inspection readiness and act as validation expert during health authority inspections.
• Contribute to remediation plans and regulatory responses for validation findings.
• Strengthen lifecycle management for facilities, utilities, equipment, and systems.
• Lead risk-based assessments to identify compliance gaps and improvement opportunities.
• Review deviations, investigations, and change controls; oversee validation documentation.
• Support remediation initiatives addressing historical validation deficiencies.
• Ensure validation strategies are scientifically sound and compliant with regulatory expectations.
• Lead qualification of manufacturing equipment, clean utilities, HVAC, water, and related systems.
• Support process/cleaning/sterilization validation and CSV/CSA programs.
• Collaborate with Engineering, QA, and site leadership to improve effectiveness.
• Conduct site assessments, gap analyses, and mock inspections focused on qualification.

Skills

Leadership

Regulatory readiness

Validation lifecycle expertise

Quality collaboration

Communication coaching

Risk-based thinking

CAPA & investigations

Vendor & cross-functional partnering

Travel readiness

Education

Bachelor's degree in Engineering/Pharmacy/C Chemistry/Life Sciences

Tools

IQ/OQ/PQ qualification

CSV/CSA

Job description

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

The Qualification & Validation Subject Matter Expert (SME) serves as the Division technical expert for commissioning, qualification, validation, and lifecycle management activities supporting sterile manufacturing operations.

You will help ensure facilities, equipment, utilities, manufacturing processes, computerized systems, laboratory systems, and sterilization programs remain compliant, inspection-ready, and aligned with current regulatory expectations throughout their lifecycle.

In this highly visible role, you'll partner with Quality, Engineering, Manufacturing, Validation, Technical Services, Automation, and site leadership teams to strengthen validation programs, address complex compliance challenges, drive continuous improvement, and support operational excellence across multiple manufacturing locations.

What You'll Be Doing

• Provide technical leadership and subject matter expertise for qualification and validation programs across manufacturing operations.
• Support regulatory inspection readiness activities and serve as a validation expert during health authority inspections, regulatory interactions, and response efforts.
• Contribute to remediation plans and regulatory responses associated with observations, Warning Letters, regulatory commitments, and significant validation findings.
• Assess and strengthen lifecycle management programs for facilities, utilities, equipment, manufacturing processes, cleaning processes, computerized systems, laboratory systems, and sterilization processes.
• Lead risk-based assessments of validation programs to identify compliance gaps, technical risks, and improvement opportunities.
• Review and provide guidance on deviations, investigations, change controls, qualification packages, validation protocols, reports, and CAPAs related to validation activities.
• Support remediation initiatives to address historical validation deficiencies, compliance gaps, and regulatory commitments.
• Ensure validation strategies are scientifically sound, risk-based, appropriately documented, and aligned with current regulatory expectations and industry best practices.
• Provide technical leadership for qualification of manufacturing equipment, clean utilities, facilities, HVAC systems, water systems, environmental control systems, and supporting infrastructure.
• Support process validation, cleaning validation, sterilization validation, and computerized systems validation/computer software assurance programs.
• Partner with Engineering, Manufacturing Science & Technology, Quality, Automation, Technical Services, and site leadership to improve validation effectiveness and compliance performance.
• Conduct site assessments, gap analyses, compliance reviews, and mock inspections focused on qualification and validation systems.
• Monitor validation program performance, identify recurring trends and systemic issues, and recommend actions to strengthen compliance.
• Drive standardization and harmonization of validation methodologies, risk assessment approaches, and qualification practices across sites.
• Coach and mentor validation, engineering, and quality teams on regulatory expectations and validation best practices.

What You'll Bring

• Bachelor's degree in Engineering, Pharmacy, Chemistry, Biological Sciences, or Life Sciences required; advanced degree preferred.
• 15+ years of experience in pharmaceutical manufacturing validation, engineering, technical services, quality, or other technical functions within regulated manufacturing environments.
• Significant experience supporting qualification and validation programs in GMP-regulated pharmaceutical manufacturing.
• Strong expertise in equipment qualification (IQ/OQ/PQ), facility and utility qualification, HVAC qualification, water system validation, process validation, cleaning validation, sterilization validation, computerized systems validation (CSV), computer software assurance (CSA), lifecycle validation management, and quality risk management.
• Deep understanding of validation lifecycle principles, data integrity requirements, and current global regulatory expectations related to qualification and validation programs.
• Demonstrated experience supporting regulatory inspections, regulatory responses, and remediation programs involving validation and qualification systems.
• Proven ability to evaluate complex technical issues, interpret regulatory requirements, and provide sound, risk-based recommendations.
• Strong investigation, root cause analysis, CAPA development, and effectiveness verification skills.
• Excellent communication, coaching, and influencing skills with the ability to effectively partner with site leadership and cross-functional technical teams.
• Experience leading or supporting large-scale remediation and compliance improvement initiatives preferred.
• Experience in sterile pharmaceutical manufacturing, injectable products, IV solutions, aseptic processing, or combination products preferred.
• Ability to travel regularly and maintain a strong on-site presence across supported manufacturing locations.

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 $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and long-term incentive. For questions about this, our pay philosophy, and available benefits,

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.

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

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

25212 W Illinois Route 120 RL/Tech|Round Lake, IL 60073|United States of America