Work Flexibility: Onsite12 month fixed term contract - onsite in CarrigtwohillWho we want:Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.What you will do: Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards. Monitoring of utilities including all grades of water, and where necessary, compressed air. Co-ordination of samples for bioburden and endotoxin testing. Ordering consumables (media etc) and general stock for day-to-day running of laboratory. Applying cGLP to all laboratory activities including stock control. Performing sampling for validations and re-qualifications as required. Review of validation files for compliance. Strong interactions, maintenance and support of sterility suppliers. Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending. Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis. Performs sterility release review, interpreting data and trends. Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving. Mentors and trains team and cross functional groups as required (induction, GMP etc) Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.Coach, mentor and train other functions in area of sterility and monitoring. What are we looking for: Bachelor's degree/ Master of Microbiology or equivalent Minimum of 6 years in Quality/Regulatory Affairs environment or 6 years Microbiology related experience. Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. Must possess effective communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously. Strong interpersonal skills. Strong written and oral communication and negotiations skills. Strong in critical thinking and "outside the box" thinking. Highly developed problem-solving skills. Strong analytical skills. Demonstrated ability to successfully manage and complete projects in a matrix organization. Demonstrated ability to work independently. Experience in working in a compliance risk situation. High proficiency in statistical techniques, data review and analysis. Desirable: Gamma and Ethylene Oxide sterilization experience#IJTravel Percentage: 10%