Microbiology Lead

Job description

This is where you save and sustain livesAt 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.SummaryBaxter in Thetford are currently recruiting for a Microbiology Lead to ensure the effective management of the Microbiology Laboratory in order to meet customer requirements both internally and externally and ensure all laboratory practices meet regulatory and corporate requirements.Role & responsibilitiesManaging the Microbiology QC LaboratoryEnsuring appropriate facility, processes, risk assessments and personnel are available for microbiological testing in line Global requirementsDriving a culture of continuous improvement within the laboratory by ensuring process performance and compliance improvement programs for the Microbiology Laboratory are identified and implementedEnsuring non-conformances impacting Microbiology Laboratory processes and initiated and investigated in compliance with Thetford local procedures, Baxter global requirements and relevant regulationsEnsuring regulatory and industry listening programs are place for the identification of best practices, regulatory trends and potential new technology and standardsEnsuring learnings from investigations, benchmarking and regulatory/industry listening activities are adequately institutionalizedHosting regulatory inspections as senior Subject Matter Expert (SME) and participate upon request in local and interplant internal audits as SMEEnsuring microbiological out of limits and out of trend results, as well as non-conformances impacting sterility assurance are fully investigated in compliance with Thetford local procedures, Baxter global requirements and relevant regulationsEnsuring a Real-time Risk Assessment Program is in place to perform the routinely review of the manufacturing facilities, equipment and processes and appropriate actions are taken to continuously eliminate or mitigate microbial contamination risksEnsuring any atypical sterilisation cycles are reviewed and dispositioned by authorized and competent personnelEnsuring all sterilisers on site are appropriately initially and periodically qualified and the sterilisation process is maintained in a validate stateEnsuring all clean room are appropriately initially and periodically qualified and performance is maintain to satisfy Annex 1 requirements as appropriateEnsure expertise is provided to impact assess changes affecting aspects relating to Sterility AssuranceEnsuring a Sterility Assurance Review takes place with Site Senior Management to review the relevant indicators and trends that demonstrate an ongoing state of control with relation to sterility assurance and determine the need for further actionExperience/Education requireDegree in Microbiology or equivalentStrong experience in Sterility AssuranceExperience in water TestingExperience in Endotoxin TestingEnvironmental Monitoring Methods and Cleanroom ClassificationsTerminal Sterilisation - Steam, ETO and Gamma SterilisationMethod ValidationAble to mentor and develop of staffPerformance managementUnderstanding of Health & Safety requirementsContinuous Improvement methodologies (e.g. 6-Sigma)#IND-UKOPSReasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.054316