Sterility Assurance Microbiologist

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.

The Role

An exciting opportunity has arisen for a Sterility Assurance Microbiologist to join our Manufacturing Quality team at Baxter. As a Sterility Assurance Microbiologist, you will play a pivotal role in supporting and influencing the achievement of Quality Systems and Good Manufacturing Practice within manufacturing and manufacturing related functions. Reporting to the Manager, Sterility Assurance and Microbiology, you will lead and support quality process improvements, manufacturing process improvements impacting product quality and process control and validation.

This exceptional opportunity allows you to apply your expertise in microbiology and sterility assurance, contributing directly to the safety and efficiency of life-saving medical products.

Your role is integral to our mission of delivering flawless healthcare solutions!

Job Responsibilities

• Troubleshoot sterility assurance operations in manufacturing, addressing issues such as Aberrant and CWO

• Assess impact and perform required testing for sterility assurance on products and processes in accordance with GQP

• Participate in internal audit programs and conduct real-time risk assessments

• Proficiently perform all testing requirements for the manufacturing facility, ensuring practices align with procedures

• Compile and ensure all testing for critical work orders, validations, and manufacturing environments are completed following shutdowns and critical systems work

• Conduct routine water testing on non-distilled and distilled water throughout the manufacturing facility

• Assist in crafting rosters for Microlab, ensuring worker rotation and distribution of duties with Microlab Manager and Microbiology Lead

• Build schedules in BAXLIMS for manufacturing environmental testing and review product and environmental results

• Review and approve atypical sterilization cycles, recommending the status of affected loads

• Assess the impact of product/process exceptions related to sterility assurance, recommending batch disposition and corrective actions

• Prepare protocols and reports for validation or projects related to processes, environmental, and microbial studies

• Review temperature monitoring in the laboratory at the required frequency

• Ensure sterility assurance risk assessments and trending are current and accessible

• Adhere to Parametric Release Regulatory requirements

• Monitor and review test results, implementing action strategies for non-conformances to ensure GMP and compliance of products for sale

• Maintain microbiology manuals and documentation to align with regulatory requirements and GMP, GDP, and GLP

• Coordinate and assist in preparing operating procedures and test specifications for new products

• Develop and recommend inspection and sampling techniques, quality control plans, and process control procedures to meet GMP quality standards

• Provide support to microbiology activities, including testing assistance, troubleshooting, evaluating results, and trending plant operations

• Assist Sterility Assurance Manager in reviewing steriliser qualifications and studies.

Key Requirements

• Tertiary degree in Microbiology, Biology, or related fields

• 3-5 years proven experience in microbiology within a manufacturing environment

• Outstanding understanding of GMP, GDP, and GLP

• Ability to strictly enforce compliance standards and successfully implement sterility assurance protocols

• Strong analytical skills to determine and troubleshoot sterility issues

• Excellent communication and collaboration skills to work effectively within a team.

Why Baxter?

At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively. Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives. Baxter is an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.

Baxter is proud to be recognized as an Inclusive Employer by the Diversity Council of Australia. We are also committed to delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of all people at work.

Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. Baxter encourages applicants of all ages.

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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.

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