Quality , Science, Pharmaceutical & Food

Microbiology Analyst

  • Contract
  • Dublin South
  • 41977856

PE Global are currently recruiting for a Senior QC Microbiologist for a client site in South Dublin.


Senior QC Microbiologist
12 Month Contract
Days position

Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. The Microbiology analyst is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. The Microbiology analyst will support manufacturing operations, as such some extended hours, shift and weekend work may
be necessary as required.

The position is in the QC Microbiology Lab (Product Team), looking after Endotoxin, sterility, Bioburden, Water utility monitoring and Lab Support duties. It is a Days Role.



Key Responsibilities:

  • Endotoxin testing of water, in-process and drug product release samples
  • Bioburden testing of water & in-process drug product samples
  • Sterility testing & Water sampling
  • Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
  • Writing technical reports
  • Perform analytical testing as a main priority with efficiency and accuracy
  • With a high degree of technical flexibility, work across diverse areas within the lab
  • Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
  • Report, evaluate, archive, trend and approve analytical data.
  • 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.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
  • Review and Approve lab results

Qualifications & Experience :

  • 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. Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills
  • Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
  • 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
  • Technically strong background in microbiology and aseptic manufacturing
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage


***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***


Interested candidates should send their CV to sean.fitzsimons@peglobal.net or call 0214297900


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