Microbiology and Sterility Assurance Lead

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

Lead Microbiologist and Sterility Assurance Specialist Compounding

Location: Dublin Ireland

Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters.

Do you want to know why is so wonderful to work for Baxter

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The Lead Microbiologist and Sterility Assurance Specialist will provide technical expertise and support to the Dublin Compounding Sites for all sterility assurance aspects. He/she will act as a valuable and effective source of information and advice on sterility assurance and will positively contribute to the network Quality Management Team. He/she will be responsible for ensuring that the Dublin Compounding Sites maintain a robust effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy.

You will be responsible for:

• Responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in Dublin Compounding facilities in compliance with current GMP and the Baxter global strategy.
• Supporting the Global compounding organization on standardization of sterility assurance practices and identification/implementation of new technology for microbiological testing and environmental control.
• Participation in continuous improvement projects and providing the expert guidance and assessment for the questions related with Sterility insurance including risk reduction initiatives in line with company strategy
• Support and lead problem solving investigations for product and process deviations or customer complaints
• Provide coaching and mentoring to other functions in problem solving with respect to Sterility Assurance
• Participate in Dublin Compounding complaints investigation Nonconformance and quality incidents investigation act as technical approver.
• Provide technical support in interpretation of Microbial Identification and Environmental Monitoring data and for the trending of EM and Microbiological data including setting of appropriate Alert limits
• Responsible for the Tracking and Reporting or Quality Metrics for internal and external use.
• Carry out validation and experimental design in association with EMEA Sterility Assurance Manager
• Qualification Auditing and monitoring the service Levels of external Lab providing the proper oversight on technical aspects
• Support the development of the quality documentation including local SOPs approval of documents related with Sterility Assurance as Technical Approver.
• Providing Microbiological training and Aseptic Operator Training for operational and quality staff including periodic reassessment.

Do you want to learn more about our business

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• Degree in Microbiology although others may be considered with relevant experience
• Required3 years experience in implementing environmental control programs and OOL investigation and correction
• Preferred5 years experience of microbiology experience in an aseptic facility
• Must have strong operational experience preferably in an aseptic manufacturing background
• Experience of aseptic technique
• Have excellent interpersonal skills
• Be a passionate advocate of quality as a discipline and continuous improvement
• Have experience in the use of quality improvement and problem solving skills (ie FMEA DMAIC Process Mapping etc) and the interpretation of data experience of Lean manufacturing
• Have experience of critical equipment and process Change Control
• Have experience of validation of microbiological methods or sanitization processes
• Able to work autonomously and take the initiative
• Demonstrate
  • Critical thinking and decision making
  • Collaboration and teamwork
  • Dealing with ambiguity
  • Good management and communication skills
  • Customer and patient focus

What we offer

Baxters aim is to save and sustain this role you will be driving the Clinical Nutrition business unit to support chronic patients as well as oncology patients to reclaim a better standard of living and independence in their daily lives.

This role will be pivotal in bringing new products to market and to develop new service offering for the non-clinical environment.

• A challenging opportunity for you and also a chance to work in a diverse and experienced team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
• Independent position with an opportunity to build your own strategy and make a real impact
• A chance to build your professional experience in the area of medical devices and pharmaceuticals simultaneously
• Internal training tailored to business needs and career goals
• Stability of employment in a recognizable and established company

  If you want to learn more about career opportunities go to we are

  Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. Youll find Baxters products and therapies on nearly every floor in almost every hospital worldwide. Youll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products.

  Our mission to save and sustain lives inspires our work and our commitment to expanding access to care providing cost-effective healthcare solutions delivering quality products and advancing innovations for the world.

  Our 50000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care.

  Our inclusive culture and a diverse workforce drives innovation creates trusted partnerships with customers suppliers and community partners and contributes to the success and sustainability of our business.

  Every day at Baxter is a chance to save and sustain peoples lives.

  Equal Opportunity Employer Discrimination: 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.

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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.

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