Microbiology Analyst

Keenova Therapeutics plc; Dublin; On-site; EUR 42,000 - 54,000; Full time

Job summary

Keenova Therapeutics plc is seeking a QC Microbiology Analyst for our College Park Dublin facility. The role focuses on QC microbiology testing, environmental monitoring, and data analysis to support manufacturing operations and external audits.

The candidate will work with QA, Validation, and Manufacturing teams to ensure schedule adherence and compliant testing practices while contributing to site safety and process improvements.

Qualifications

• Minimum BSc in Science or equivalent (level 7).
• Minimum 2 years’ experience in a similar QC microbiology role.
• Must have experience in a QC setting and strong writing skills.

Responsibilities

• Perform QC microbiology testing and environmental monitoring.
• Coordinate testing schedules and report results timely.
• Support audits (e.g., HPRA, FDA) and regulatory compliance.
• Liaise with other on-site functions to ensure testing continuity.

Skills

Data analysis

Communication

Teamwork

Education

BSc in Science or equivalent

Tools

Excel

Word

Job description

Job Title Microbiology Analyst Requisition JR000015986 Microbiology Analyst (Open) Location College Park, Dublin - IRL006 Additional Locations

Job Description Summary

The Quality Control (QC) Microbiology Analyst is responsible for QC Microbiology testing within the QC laboratory and CPMF Manufacturing Area to support the College Park Manufacturing Facility. The role will ensure adherence with regulatory and best practice requirements while delivering consistently for the internal and external customers.

Essential Functions

Ability to perform key tasks such as:

• Environmental Monitoring
• Water Sampling
• Water Testing
• Total Organic Carbon Testing
• Conductivity Testing
• Bioburden Testing
• Endotoxin Testing
• Compendial Verifications
• Method Transfer Validations
• Growth Promotion Testing
• In-process testing
• Data analysis and trending
• Perform testing and ensure that the testing schedule is adhered to and the results reported in a timely manner, escalation of any issues LIR/OOS/OOT/etc.
• Liaise with other functions on site to facilitate testing to ensure schedule adherence.
• Oversight of contract testing laboratories associated with Microbiological Testing– shipping, reconciliation and trending of test results
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Participate in the Compendial verification, validation and transfer of Microbiological Testing in house.
• Prepare for and support internal and external audits (e.g. HPRA, FDA, Corporate etc.).
• Lead and implement initiatives that add value to QC Microbiology and site operations.

Minimum Requirements Education / Experience / Skills:

• Minimum BSc in Science or equivalent level (level 7 Laboratory apprentice qualification)
• Minimum 2 years’ experience in a similar role
• Must include role(s) within a QC setting
• Solid experience of Bioburden, Endotoxin and Environmental Monitoring preferred
• Experience with method validation/method development preferable
• Pharmaceutical drug/process development experience preferable
• Self-starter with strong work ethic
• Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• Must be able to function effectively in a teamwork environment
• Ability to identify, execute and prioritize work tasks/projects and know when to escape
• Excellent problem-solving, decision-making and communication skills
• Good computer skills, including proficiency with business and technical software (Word, Access, Excel, PowerPoint)
• Ability to plan, organize, and prioritize effectively
• Good technical and compliance-based writing skills
• High levels of integrity and trustworthiness

Organizational Relationship/Scope:

Reporting to the QC & Microbiology Lead the QC Microbiology Analyst is required to perform testing and analysis within QC Microbiology. The QC Microbiology Analyst works closely with Senior QC Microbiology Analyst and QC Microbiology Analysts within the lab and cross functionally with including but not limited to QC, QA, Validation, Engineering and Manufacturing across College Park. The QC Microbiology Analyst is also required to liaise with and work with the wider Global Quality function.

Working Conditions:

This is a lab-based role. Working hours follow days/evenings pattern At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence. We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference. We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com. At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Keenova and let’s do something dynamic together. Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Keenova’s hiring practices may be found by clicking