Sterility Assurance Manager I

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world.

You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.

Your role at Baxter

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 product as outlined in the below job.

Your Team at Baxter

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.

What we offer from Day One

• 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

What you'll be doing :

• 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 the 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.

What you'll bring :

• Bachelor’s Degree in Microbiology, Biology, or related science.
• Seven (7) to 10 years confirmed experience in cGMP related industry, with five (5) or more years of work experience in sterility assurance.
• Five (5) or more years of proven leadership / supervision and experience within an aseptic or sterile manufacturing site.
• Knowledge of aseptic and terminal sterilization processing.
• Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.

e., process air, water for injection, etc.).

• Knowledge of standard microbiological procedures (environmental monitoring, bioburden, bacterial endotoxin testing).
• Knowledge of FDA cGMP, EU Annex-I, ISO 14644-1 standards.
• Expert knowledge in aseptic technique, clean-room behavior and practice, cleaning methodologies, and risk assessments.
• Strong communication and project management skills.
• Must have good analysis, troubleshooting, and investigative skills including knowledge and understanding of problem-solving methodologies (DMAIC, Ishikawa Diagram).
• Must have strong technical writing skills and ability to put thoughts and issues into writing in such a manner to be understood by the reader
• Able to confidentially interacting with FDA or similar regulatory agencies

Other Duties as Assigned