
Microbiology QC Testing
3 weeks ago
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Microbiology QC Testing - Manufacturing Support, Dublincol-narrow-left
Client:JobContax
Location:Dublin, Ireland
Job Category:Other
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EU work permit required:Yes
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Job Reference:b39f04b1ae6b
Job Views:6
Posted:12.08.2025
Expiry Date:26.09.2025
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Job Description:Microbiology QC Testing , Manufacturing Support - Dun Laoghaire, Dublin
Employment Type:Contract
Work Location:On Site
Experience:3+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, 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.
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.
This role 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.
This role will support manufacturing operations, as such some extended hours, shift and weekend work may
be necessary as required.
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
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
May participate in lab investigations.
May provide technical guidance.
May train others.
May contribute to regulatory filings.
May represent the department/organization on various teams
May interact with outside resources
Requirements
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
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)
Escalate issues professionally and on a timely basis
Teamwork and Coaching others
Negotiation and Influence 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
Technically strong background in microbiology and aseptic manufacturing
Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
Flexibility – the role often encounters changing priorities (also required to work weekend on call – Rota system)
Demonstrated ability to work independently and deliver right first time results
Works under minimal direction, Recognizes and escalates problems
Work is guided by objectives of the department or assignment
Follows procedures
Refers to technical standards, principles, theories and precedents as needed
May set project timeframes and priorities based on project objectives and ongoing assignments.
Package
Location: Fully onsite, with hours from 08:00 to 17:00.
On-Call: You'll be on rotation every 8 weeks.
If a bioburner sample pops up, you'll need to step in and handle the testing.
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