Associate QC Microbiology Specialist, Carlow

Orion Group Life Sciences are currently recruiting an Associate QC Microbiology Specialist on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11‑Month contract with potential to extend.

Monday - Friday role, 8:00- 16:30 and will be fully onsite.

Key Responsibilities

Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.

Supporting and owner of Environmental monitoring risk assessments and qualification.

Generation of quarterly and annual trend reports.

Understanding and applying regulatory/compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.

Development and execution of Microbiology test methods and project validations.

Troubleshooting of issues which arise during the execution of validation studies and routine tests.

Development of training modules.

Microbiology Support to Site Investigations and projects relating to environmental monitoring and utilities monitoring.

Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.

Authoring and managing change controls, procedures, test methods and deviations.

Result authorization for microbiological samples to support batch release.

GLIMS System updates.

Assessing compendial and quality manual updates pertaining to the Microbiology Lab&environmental control.

Supporting lab stock management and financial control as required.

Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests.

Making decisions within guidelines and policies which impact microbiology projects.

Ensuring highest safety standards.

Performing other duties as assigned.

Qualifications Required

Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or a related Life Sciences field.

Minimum 3 years of hands‑on experience in microbiology/QC, specifically in environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis.

Ability to author procedures, change controls, deviations, reports, and work in line with regulatory/compendial requirements.

Strong troubleshooting, decision-making, and ability to drive improvements such as lean lab initiatives and method optimization.

Strong microbiology background and strong understanding of aseptic processing, environmental monitoring programs, and contamination control in sterile manufacturing.

Experience in a GMP QC laboratory with knowledge of regulatory expectations.

Familiarity with ALCOA(+) data integrity principles, electronic laboratory systems, and controlled documentation.

Entry- to early-career level with growing technical competence; able to perform routine tasks with limited discretion.

Preferred

Experience with problem solving, decision making, scheduling of laboratory testing/tasks

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