Job details
12 month fixed term contract - onsite in Carrigtwohill
Who 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
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Posted Date: 02/18/2026
This role will be posted for a minimum of 3 days.
