Aseptic Manufacturing Microbiologist

Job Summary

We are seeking a skilled Microbiologist to join our team. The successful candidate will be responsible for performing microbiological testing, method transfers, sample and data management, and equipment maintenance in a quality control (QC) laboratory.

About the Role

This is an exciting opportunity for an experienced and technically strong associate to contribute to the quality of tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within the team.

The role will support manufacturing operations, and some extended hours, shift, and weekend work may be necessary as required.

Responsibilities

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• Perform analytical testing as a main priority with efficiency and accuracy.">
• Endotoxin testing of water, in-process, and drug product release samples.">
• Bioburden testing of water & in-process drug product samples.">
• Sterility testing.">
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications, and Autoclave.">
• Writing technical reports.">
• Troubleshoot, solve problems, and communicate with stakeholders.">
• Initiate and/or implement changes in controlled documents.">
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.">
• Write protocols and perform assay validation.">
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.">
• Review and Approve lab results.">
• May participate in lab investigations.">
• May provide technical guidance.">
• May train others.">
• May contribute to regulatory filings.">

Requirements

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• Bachelors degree in a science discipline.">
• Biopharmaceutical QC experience in a microbiology lab.">
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.">
• Experience working in endotoxin, bioburden, or sterility testing.">
• Proficient in GMP systems such as LIMS Labware & LMES.">
• Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.">
• Understanding and application of principles, concepts, theories, and standards of GMP QC microbiology laboratories.">
• Knowledge of related regulatory/industry considerations, compliance issues, and/or scientific discovery Skills.">
• Take initiative to identify and drive improvements.">
• Excellent verbal and written communication skills.">
• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls).">
• Presentation skills.">
• Escalate issues professionally and on a timely basis.">
• Decision Making skills.">
• Teamwork and Coaching others.">
• Negotiation and Influence skills.">
• Problem solving skills.">
• Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope.">
• Ensures compliance within regulatory environment.">
• Develops solutions to technical problems of moderate complexity.">
• Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues.">
• Interprets generally defined practices and methods.">

Benefits

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• Contract role - Hourly rate €25 - €35 per hour.">
• Minimum 12 month contract.">
• Fully onsite, with hours from 08:00 to 17:00.">
• On-Call: You'll be on rotation every 8 weeks.">

About Us

We are a leading international Biotechnology company with a state-of-the-art aseptic manufacturing facility in Dun Laoghaire, South Dublin.

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.