Senior Manager, Sterility Assurance

Senior Manager, Sterility Assurance

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.

This is where your creativity addresses challenges

This role is to ensure site policies, programs, procedures, and practices are in place to meet established requirements for contamination control of clean-rooms, manufacturing processes, and products. To implement and drive continuous improvement initiatives within the Sterility Assurance Program.

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

• Develop, implement, and drive continuous improvement initiatives within the Sterility Assurance program.
• Recognizes and assures conformance to regulations applicable to sterility assurance. Serve as Sterility Assurance SME during routine audits by regulatory agencies, internal corporate auditors, and external auditors.
• Provide microbiological expertise including, but not limited to, SOPs, change control, and validations.
• Assist in the development, documentation, and management of the site contamination control strategy.
• Through continuous improvement efforts, work to prioritize and improve cleaning procedures across multiple operating lines and areas.
• Provide oversight and Sterility Assurance expertise to Operations to assure all applicable regulatory requirements are met.
• Write, review, and/or approve environmental cleaning protocols to support cleaning practices.
• Design and implement training program(s) for cleanroom behavior and contamination control practices.
• Responsible for microbiological/sterility assurance risk assessment.
• Support ongoing projects throughout the facility by completion of environmental FMEAs, assessing potential impact of proposed changes, supplying to the design of projects, and performing risk assessments.
• Coordinate responses to environmental and process conditions detected during Real Time Risk Assessments (RTRA).
• Perform and/or participate in root cause investigations for microbiological and manufacturing nonconformances. Collaborate with microbial investigators and manufacturing compliance teams to resolve potential CAPA items in response to microbial out of limits.
• Establish appropriate response plans to environmental events in clean-rooms.
• Write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews.
• Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement.
• Work in partnership with regional sterility assurance authorities to achieve company objectives and ensure policy alignment across site.