Quality Compliance – Sterility Assurance SME

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

Job summary

Baxter International is seeking a Sterility Assurance Subject Matter Expert (SME) to lead sterile manufacturing quality programs across multiple sites. You will drive contamination control strategies, elevate regulatory readiness, and mentor cross-functional teams in sterile operations.

The role requires deep expertise in aseptic processing, environmental monitoring, and microbiological quality systems, with strong collaboration across Quality, Operations, and Engineering functions.

Qualifications

• Bachelor's degree in Microbiology or closely related field.
• 15+ years of experience in sterile pharmaceutical manufacturing or related disciplines.
• Deep expertise in sterility assurance and aseptic processing within regulated environments.
• Experience supporting regulatory inspections and leading remediation initiatives.

Responsibilities

• 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 improvements in sterile operations.
• Support regulatory inspection readiness and act as SME during health authority inspections.
• Lead assessments of aseptic processes, environmental monitoring, sterilization, and facility controls.
• Review contamination events, investigations, CAPAs, and trends to drive improvements.
• Collaborate with Quality, Operations, Engineering, Validation, and Microbiology teams.
• Drive remediation and continuous improvement initiatives with risk-based solutions.
• Conduct site assessments, mock inspections, and gap analyses to identify opportunities.
• Analyze performance trends and share best practices across sites.
• Coach teams on sterile manufacturing and regulatory expectations.

Skills

Sterility assurance

Aseptic processing

Contamination control

Environmental monitoring

Regulatory readiness

Cross-functional collaboration

Communication skills

Travel availability

Education

Bachelor's degree in Microbiology

Tools

CAPA systems

Environmental monitoring programs

Sterility testing equipment

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

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.

This is a highly impactful role where you'll help shape contamination control strategies, support regulatory readiness, solve complex quality challenges, and elevate sterility assurance practices across multiple manufacturing sites.

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, elevate 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.

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 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

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