Microbiology Analyst

Collins McNicholas; Dublin; On-site; EUR 42,000 - 56,000; Full time

Benefits offered by this job

Weekend shift allowance

Job summary

Collins McNicholas Group in Ireland (Dublin region) seeks a QC Microbiology Analyst for weekend shifts to support microbiological testing, environmental monitoring and area qualification in a regulated manufacturing setting.

You will work with the QC Microbiology team performing testing, method transfers and investigations, while ensuring compliance with GxP and regulatory expectations. Training and CAPA activity are included.

Qualifications

• Minimum BSc in Microbiology or related science.
• Postgraduate degree desirable.
• 2-3 years' microbiology analyst experience.
• Experience in aseptic techniques and EM, bioburden, endotoxin testing.
• Experience in sterile manufacturing or pharmaceutical environments desirable.
• Experience gowning in Grade C/D environments.
• Experience protocol/report writing for water/EM testing.
• Familiarity with Milliflex Plus pump systems advantageous.

Responsibilities

• Perform microbiological testing in QC Microbiology lab.
• Carry out Environmental Monitoring and related testing.
• Maintain testing schedules and report results promptly.
• Assist investigations and CAPAs as needed.
• Support audits and regulatory compliance.
• Collaborate with QC Microbiology Lead and site teams.
• Train team members in microbiological methods.
• Coordinate with external contract labs for sample shipments.

Skills

Microbiology SME

Instrument troubleshooting

Technical writing

Problem solving

Communication skills

Independent work

Team collaboration

Regulatory compliance

IT skills

SAP familiarity

Education

BSc in Microbiology

Postgraduate degree desirable

Tools

Milliflex Plus

Endotoxin MCS systems

Job description

Microbiology Analyst - Weekend Shift

Working Hours: Friday - Sunday | 12-hour shifts

We are seeking a skilled and motivated QC Microbiology Analyst to join a well-known pharmaceutical company based in Dublin 15. This is an excellent opportunity to join a leading organisation within the pharmaceutical industry, supporting quality and compliance within a regulated manufacturing environment.

Working as part of the Quality Control (QC) Microbiology team, you will be responsible for microbiological testing, environmental monitoring and classified area qualification programmes within the manufacturing facility.

This position operates on a weekend shift pattern, working Friday to Sunday on 12-hour shifts, offering an opportunity to work within a highly regulated pharmaceutical environment while benefiting from a dedicated weekend shift allowance and an attractive benefits package.

Key Responsibilities:

• Perform microbiological testing within the QC Microbiology laboratory, ensuring accurate, timely and compliant delivery of results.
• Carry out Environmental Monitoring (EM), water sampling and testing, bioburden and endotoxin testing, in-process testing and growth promotion testing of media and diluents.
• Perform compendial verifications, method validations and microbiological testing transfers.
• Ensure testing schedules are maintained, results are reported promptly, and any out-of-specification (OOS), out-of-trend (OOT) results or other issues are escalated appropriately.
• Support environmental excursion investigations, microbiological investigations and manufacturing area risk assessments, including HACCP.
• Draft, review and execute SOPs, protocols, technical reports, training materials, deviations, investigations and CAPAs.
• Maintain laboratory equipment calibration schedules and ensure equipment is fit for purpose.
• Coordinate with external contract testing laboratories, including sample shipment, reconciliation and trending of results.
• Ensure compliance with GxP requirements, site safety standards, environmental procedures and regulatory expectations.
• Support internal and external audits, including HPRA, FDA and corporate audits.
• Provide technical expertise and troubleshooting support for microbiological methods, instruments and laboratory processes.
• Train team members in microbiological methods and support the development of technical capabilities within the laboratory.
• Collaborate with the QC Microbiology Lead and wider site teams to ensure the effective running of the laboratory.
• Contribute to quality improvement initiatives, site projects and global microbiology and quality programmes.

Requirements:

• Minimum BSc in Microbiology or a related scientific discipline.
• A postgraduate or advanced degree is desirable.
• Minimum of 2-3 years’ experience in a microbiology analyst role.
• Experience in aseptic techniques, environmental monitoring, clean utilities testing, bioburden, endotoxin, microbial identification, plate reading, growth promotion and in-process testing.
• Experience working within a sterile manufacturing, biotechnology or pharmaceutical environment is highly desirable.
• Experience gowning and working in classified areas, such as Grade C and Grade D.
• Experience writing and executing protocols and reports for water, environmental monitoring and product testing.
• Experience investigating environmental excursions and training colleagues in microbiological methods.
• Familiarity with Milliflex Plus pump systems and endotoxin MCS systems is advantageous.

Skills and Competencies:

• Strong microbiological knowledge, with the ability to act as a Subject Matter Expert (SME).
• Good instrument troubleshooting and microbiological method troubleshooting skills.
• Strong technical writing, documentation and compliance skills.
• Excellent problem-solving, decision-making and communication skills.
• Ability to work independently, prioritise tasks and meet deadlines in a fast-paced, target-driven environment.
• Strong interpersonal skills and the ability to collaborate effectively within a team.
• Proactive approach to quality, safety, continuous improvement and regulatory compliance.
• Good IT skills, including Microsoft Word, Excel, PowerPoint, Access and SAP.
• Ability to adapt to changing priorities while maintaining high standards of accuracy and compliance.
• High levels of integrity, accountability and professionalism.