Sterility Assurance Manager I - Quality Leadership Role in Baxter's Sterility Assurance Program

Join Baxter: Where Saving and Sustaining Lives is Our Mission

At Baxter, we're driven by a singular purpose: to save and sustain lives. For over 85 years, our innovative medical solutions have transformed healthcare, touching the lives of millions of patients worldwide. Our products and therapies are found in almost every hospital, clinic, and home. We're a team united by our mission, and we invite you to be a part of it. As a Sterility Assurance Manager I, you'll play a critical role in ensuring the highest standards of quality and sterility in our manufacturing processes.

About the Role

We're seeking an experienced Sterility Assurance Manager I to lead our Sterility Assurance program, ensuring site policies, programs, procedures, and practices meet established requirements for contamination control and sterility assurance. As a subject matter expert, you'll provide microbiological expertise, develop and implement continuous improvement initiatives, and collaborate with cross-functional teams to drive quality excellence.

Key Responsibilities:

• Develop, implement, and drive continuous improvement initiatives within the Sterility Assurance program, prioritizing and improving cleaning procedures across multiple operating lines and areas.
• Recognize and assure conformance to regulations applicable to sterility assurance, serving as a Sterility Assurance SME during routine audits by regulatory agencies, internal corporate auditors, and external auditors.
• Provide microbiological expertise, including SOPs, change control, and validations, and assist in the development, documentation, and management of the site contamination control strategy.
• Design and implement training programs for cleanroom behavior and contamination control practices, and provide oversight and Sterility Assurance expertise to Operations to ensure all applicable regulatory requirements are met.
• Write, review, and/or approve environmental cleaning protocols, perform regular GEMBA-style assessments of manufacturing operations, and collaborate with microbial investigators and manufacturing compliance teams to resolve potential CAPA items.
• Establish appropriate response plans to environmental events in clean-rooms, and write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews.

What You'll Bring:

Essential Qualifications:

• Bachelor's Degree in Microbiology, Biology, or a related science.
• Seven (7) to 10 years of confirmed experience in a cGMP-related industry, with five (5) or more years of work experience in sterility assurance.
• Five (5) or more years of proven leadership/supervision experience within an aseptic or sterile manufacturing site.
• Knowledge of aseptic and terminal sterilization processing, contamination control practices, and engineering controls for cleanroom operations and critical systems.
• Expert knowledge in aseptic technique, clean-room behavior and practice, cleaning methodologies, and risk assessments.
• Strong communication and project management skills, with good analysis, troubleshooting, and investigative skills.

Preferred Qualifications:

• Experience with FDA cGMP, EU Annex-I, and ISO 14644-1 standards.
• Knowledge of standard microbiological procedures, including environmental monitoring, bioburden, and bacterial endotoxin testing.
• Experience with problem-solving methodologies, such as DMAIC and Ishikawa Diagram.

What We Offer:

Compensation and Benefits:

• Competitive salary range of $80,000 to $180,000 per year, with an annual incentive bonus.
• Comprehensive benefits package, including medical, dental, and vision coverage.
• 160 hours of Paid Time Off and Paid Holidays.
• 401K match and Employee Stock Purchase Program.
• Paid Parental Leave and Tuition Reimbursement.

Career Growth Opportunities:

• Opportunities for professional growth and development in a dynamic and innovative industry.
• Collaborative and supportive work environment with a team of experienced professionals.
• Access to cutting-edge technologies and training programs.

Our Culture:

At Baxter, we're committed to creating a work environment that's inclusive, diverse, and supportive. We value our employees' well-being and offer a range of programs and benefits to support their physical and mental health. Our culture is built on the principles of respect, integrity, and accountability, and we're dedicated to fostering a sense of community and teamwork.

How to Apply:

If you're a motivated individual ready to contribute to a thriving team, we encourage you to apply now! Please submit your application, including your resume and cover letter, and we'll be in touch to discuss this exciting opportunity further.

At Baxter, we're excited to welcome new team members who share our passion for saving and sustaining lives. Apply today and join our mission-driven team!