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About the Role

The Sterility Assurance Specialist provides technical expertise and support for sterility assurance and environmental control and monitoring processes in UK and Ireland Compounding Sites, aligning with global strategy. This role contributes to the network Quality Management Team and ensures robust, effective, and compliant operations.

Responsibilities

• Ensuring effective Sterility Assurance and Environmental Monitoring programmes are deployed in UK and Ireland Compounding facilities, in compliance with current GMP and Baxter global strategy.
• Providing technical support and guidance on Sterility Assurance, Environmental Monitoring, environmental control, Contamination Control Strategy, and aseptic practices across UK and Ireland Compounding facilities.
• Supporting risk management activities relating to Sterility Assurance, Environmental Monitoring, Contamination Control Strategy, and aseptic practices, including support of site RTRA processes.
• Supporting the Global Compounding organization on standardization of Sterility Assurance practices and identification and implementation of new technology for microbiological testing and environmental control.
• Participating in continuous improvement projects and providing expert guidance and assessment for Sterility Assurance related questions, including risk reduction initiatives.
• Providing coaching, mentoring, and technical guidance to operational and quality teams in relation to Sterility Assurance, Environmental Monitoring, environmental control, and aseptic practices.
• Providing technical oversight and interpretation of validation, qualification, or study data related to Sterility Assurance, Environmental Monitoring, environmental control, and aseptic practices.
• Supporting inspection readiness and participating in internal, corporate, and regulatory audits as the technical representative for Sterility Assurance, Environmental Monitoring, environmental control, and aseptic practices.
• Reviewing and assessing Environmental Monitoring reports and protocols to ensure compliance with regulatory and internationally acceptable standards.
• Supporting and leading problem-solving investigations for product and process deviations or customer complaints.
• Participating in complaint investigation, non-conformance, and quality incidents investigation, acting as technical approver where required.
• Providing technical input to change controls where Sterility Assurance, Environmental Monitoring, Contamination Control Strategy, environmental control, or aseptic practices may be impacted.
• Providing technical support in the interpretation of microbial identification and Environmental Monitoring data, including trending and setting appropriate Alert limits.
• Supporting Environmental Monitoring Management Software approval, configuration, and reporting.
• Tracking and reporting Quality Metrics for internal and external use.
• Supporting the development and review of quality documentation including local SOPs and documents related to Sterility Assurance, Environmental Monitoring, Contamination Control Strategy, and aseptic practices, acting as document owner or Technical Approver.
• Providing microbiological expertise, training, and operational guidance to operational and quality staff on Sterility Assurance, Environmental Monitoring, environmental control, and aseptic practices, including periodic reassessment.
• Identifying new, or changes to existing, processes and systems to improve the effectiveness and efficiency of the Sterility Assurance program while maintaining compliance with Corporate and Regulatory requirements.
• Adhering to Environmental Health & Safety (EHS) policies, procedures, and requirements.
• Supporting the maintenance of a safe place to work through escalation of unsafe EHS practices.
• Maintaining professional status and standards.
• Fully supporting the Quality Policy and business goals and objectives by building quality into all aspects of work.
• Performing any other tasks assigned by the Sterility Assurance Manager.

Requirements

• 3 years’ experience in implementing environmental control programs and OOL investigation and correction.
• Strong operational experience, preferably in an aseptic manufacturing background.
• Experience of aseptic technique.
• Experience in the use of quality improvement and problem-solving skills (e.g., FMEA, DMAIC, Process Mapping) and the interpretation of data.
• Experience of critical equipment and process Change Control.
• Ability to work autonomously and take the initiative.
• Demonstrated critical thinking and decision making.
• Demonstrated collaboration and teamwork.
• Demonstrated ability to deal with ambiguity.
• Demonstrated good management and communication skills.
• Demonstrated customer and patient focus.
• Adherence to Environmental Health & Safety (EHS) policies, procedures, and requirements.
• Support maintenance of a safe place to work through escalation of unsafe EHS practices.
• Maintain professional status and standards.
• Fully support the Quality Policy and business goals and objectives by building quality into all aspects of work.

Skills

• Sterility Assurance
• Environmental Monitoring
• Contamination Control Strategy
• Aseptic practices
• Risk management
• Microbiological testing
• Microbial identification
• Data trending
• Quality Metrics reporting
• Lean Management principles
• MS Office applications (Word, Excel, PowerPoint, SharePoint, Office 365)
• Quality improvement tools (FMEA, DMAIC, Process Mapping)
• Process Change Control

Location

• UK
• Ireland

Work Type

• Full-time

Experience Level

• 3 years experience
• 5 years experience preferred

Education Level

• Degree in Microbiology or other Life Sciences degrees with relevant experience

Benefits

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance

About the Company

• At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life.
• 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.

Equal 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.
• 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.