Job Description
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Employment Type: Contract
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 Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland, currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.
Responsibilities
* Environmental Monitoring of Grade 8/9 Cleanrooms
* Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
* Reading of Environmental Monitoring Plates
* Bioburden testing of water & disinfectants
* Writing technical reports
* Testing of In-Process samples such as Protein Concentration, Density & pH
Requirements
* Biopharmaceutical QC experience in a microbiology lab
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
* Experience working in an aseptic cleanroom performing Environmental Monitoring
* Proficient in the use of LIMS & LMES
* Strong technical background in microbiology and aseptic manufacturing
* Experience with LIMS, Change Control, Trackwise, SAP, and CDOCS is advantageous
* Flexibility to adapt to changing priorities
* Experience with regulatory inspectors and interactions is desirable
* Ability to work independently and deliver accurate results
* Ability to follow procedures and refer to technical standards, principles, and precedents as needed
* Ability to set project timeframes and priorities based on objectives
* Ability to recognize and escalate problems
* Strong leadership and communication skills
* Experience in auditing documentation and operational processes
* Ability to interact with regulatory agencies
Package
* Minimum 12-month contract with the possibility of extension
* Work pattern: 12-hour shifts (days and nights including weekends), approximately 35%
* Support manufacturing operations on a 24/7 shift pattern, with potential for extended hours
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