Senior Lead, Microbiology & Sterility Assurance
Baxter · Cartago
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 at Baxter
As a senior leader within Quality, you will provide technical and people leadership for Baxter Cartago’s Microbiology and Sterility Assurance programs. You will serve as the site subject matter expert, influencing quality decisions, regulatory compliance, risk management, and sterilization strategies across the organization.
In this role, you will lead a team of technical professionals, partner with cross-functional stakeholders, and ensure microbiological controls and sterilization processes remain effective, compliant, and aligned with global standards. Your ability to combine scientific expertise, regulatory knowledge, and people leadership will help drive business performance while protecting patients and customers.
What You'll Be Doing
- Lead the site’s Microbiology and Sterility Assurance programs, ensuring compliance with regulatory requirements, industry standards, and Baxter quality expectations.
- Provide technical oversight for microbiological monitoring activities, including environmental monitoring, bioburden testing, bacterial endotoxin testing, microorganism identification, and manufacturing area controls.
- Guide sterilization processes and validation activities, including radiation sterilization programs, routine monitoring, requalification activities, dosimetry, and change assessments.
- Serve as the site subject matter expert during regulatory inspections, customer audits, internal audits, and technical reviews, ensuring scientifically sound and compliant outcomes.
- Drive investigations, corrective and preventive actions (CAPAs), risk assessments, and change control activities related to microbiology, laboratory operations, and sterilization processes.
- Develop and mentor a high-performing team by setting priorities, strengthening technical capabilities, supporting career development, and building future subject matter experts.
- Identify quality trends, risks, and improvement opportunities through data analysis, helping maintain validated processes and advance operational excellence.
What You'll Bring
Required Qualifications
- Bachelor’s degree in Microbiology, Biotechnology Engineering, Life Sciences, or a related scientific discipline.
- 5+ years of progressive experience in microbiology, sterilization, sterility assurance, or quality laboratory operations within a regulated industry such as medical devices, pharmaceuticals, or life sciences.
- 2+ years of leadership experience managing or supervising technical professionals.
- Hands-on experience with microbiological controls, environmental monitoring, bioburden testing, bacterial endotoxins, and sterilization processes.
- Strong knowledge of applicable regulations and standards, including ISO 13485, ISO 14971, ISO 11137, and medical device quality systems.
- Advanced English communication skills, both written and verbal.
- Experience leading investigations, risk assessments, root cause analysis, CAPA activities, and quality decision-making processes.
Preferred Qualifications
- Direct experience within the medical device industry.
- Expertise in radiation sterilization technologies, including E-Beam and/or Gamma sterilization.
- Experience supporting regulatory inspections, notified body audits, or corporate quality audits.
- Knowledge of validation and qualification activities, including process validation, equipment qualification, computerized systems validation, and test method validation.
- Experience applying structured problem-solving methodologies such as 5 Whys, Fishbone, or 8D.
- Proficiency with data analysis and reporting tools such as Excel, Power BI, or similar platforms.
- Additional training or certifications in industrial microbiology, sterilization technologies, auditing, or quality risk management.
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.
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.