Quality Compliance – Sterility Assurance SME
Baxter International Inc.
Summary
Sterility Assurance Subject Matter Expert (SME) serves as the enterprise technical expert for sterility assurance, aseptic processing, contamination control, and microbiological risk management across manufacturing sites. You'll work directly with site leadership and cross-functional teams to strengthen sterile manufacturing operations, reduce compliance risk, and drive world-class quality standards.
Job description
What You'll Be Doing
- Provide technical leadership for sterility assurance, aseptic processing, contamination control, and microbiological quality systems.
- Partner with manufacturing sites to assess risks, identify gaps, and implement sustainable improvements in sterile operations.
- Support regulatory inspection readiness and serve as a key subject matter expert during health authority inspections and interactions.
- Lead assessments of aseptic processes, contamination control programs, environmental monitoring systems, sterilization processes, utilities, and facility controls.
- Review and provide guidance on contamination events, sterility failures, investigations, deviations, CAPAs, environmental monitoring trends, and microbiological excursions.
- Collaborate with Quality, Operations, Engineering, Validation, and Microbiology teams to strengthen contamination control strategies and quality risk management practices.
- Drive remediation and continuous improvement initiatives, ensuring solutions are risk-based, effective, and sustainable.
- Conduct site assessments, mock inspections, compliance reviews, and gap analyses to proactively identify improvement opportunities.
- Analyze performance trends, escalate critical risks, and share best practices across manufacturing sites.
- Coach and mentor technical teams on sterile manufacturing, contamination control, aseptic behaviors, and regulatory expectations.
- Help ensure alignment with evolving global regulatory requirements and industry best practices.
What You'll Bring
- Bachelor's degree in Microbiology required; advanced degree preferred.
- 15+ years of experience in sterile pharmaceutical manufacturing, Sterility Assurance, Quality, Microbiology, Validation, Manufacturing Science, or similar technical disciplines.
- Deep expertise in sterility assurance, aseptic processing, contamination control, and microbiological quality systems within regulated pharmaceutical manufacturing environments.
- Strong knowledge of global regulatory expectations and industry standards governing sterile manufacturing operations.
- Proven experience supporting regulatory inspections, responding to health authority observations, and leading complex remediation and compliance improvement initiatives.
- Hands-on experience with contamination control strategy development and implementation, environmental monitoring, cleanroom operations, aseptic processing, media fills, sterilization processes, cleaning and disinfection programs, microbiological investigations, and quality risk management.
- Demonstrated ability to assess complex technical issues, apply sound risk-based decision making, and provide clear, independent quality recommendations.
- Strong investigation, root cause analysis, CAPA development, and effectiveness verification capabilities.
- Excellent communication, coaching, and influencing skills with the ability to build credibility and effectively partner with site leadership and cross-functional teams.
- Experience with injectable products, sterile solutions, aseptic filling operations, terminal sterilization processes, or combination products is preferred.
- Ability to travel regularly and maintain a strong on-site presence across supported manufacturing locations.
Requirements
- Bachelor's degree in Microbiology required; advanced degree preferred
- 15+ years of experience in sterile pharmaceutical manufacturing, Sterility Assurance, Quality, Microbiology, Validation, Manufacturing Science, or similar technical disciplines
- Deep expertise in sterility assurance, aseptic processing, contamination control, and microbiological quality systems within regulated pharmaceutical manufacturing environments
- Strong knowledge of global regulatory expectations and industry standards governing sterile manufacturing operations
- Proven experience supporting regulatory inspections, responding to health authority observations, and leading complex remediation and compliance improvement initiatives
- Hands-on experience with contamination control strategy development and implementation, environmental monitoring, cleanroom operations, aseptic processing, media fills, sterilization processes, cleaning and disinfection programs, microbiological investigations, and quality risk management
- Demonstrated ability to assess complex technical issues, apply sound risk-based decision making, and provide clear, independent quality recommendations
- Strong investigation, root cause analysis, CAPA development, and effectiveness verification capabilities
- Excellent communication, coaching, and influencing skills with the ability to build credibility and effectively partner with site leadership and cross-functional teams
- Experience with injectable products, sterile solutions, aseptic filling operations, terminal sterilization processes, or combination products is preferred
- Ability to travel regularly and maintain a strong on-site presence across supported manufacturing locations
- Applicants must be authorized to work for any employer in the U.S.
Benefits
- Medical & Dental Day One
- Life & Disability Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.