Qualification & Validation Subject Matter Expert (SME) Round Lake, IL

Job description

Qualification & Validation Subject Matter Expert (SME) Req # 213394 Location Round Lake, Illinois, United States Job Category Quality Date posted 11/13/2026 Apply Now Overview This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. • Support for Parents • Continuing Education/ Professional Development • Employee Health & Well-Being Benefits • Paid Time Off • 2 Days a Year to Volunteer Success Profile What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit. • Detail Oriented • Continuous Learner • Courageous • Collaborative • Critical Thinker • Influential Qualification & Validation Subject Matter Expert (SME) Apply Now 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 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 on 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, 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