About the Role:
We are seeking a skilled professional to join our team as a QC Microbiology Scientist in Dundalk, Ireland.
As a key member of our quality control microbiology group, you will be responsible for ensuring the quality and safety of our biologics products.
* You will be responsible for ensuring tasks associated with startup and routine operations of a QC Microbiology laboratory are carried out safely
* You will support the setup of the QC Microbiology lab, including design and construction queries, equipment installation, and qualification
* Microbial organism identification, supporting facility qualification, cleaning validation, process validation, etc.
* You will develop and maintain quality systems within the QC Microbiology Laboratory to ensure compliance to cGLP
* You will support commissioning/qualification activities of utility systems, including Water systems, Clean Steam, and process gases
* Aiding in the identification and development of Contract Test laboratories and strategies
* Development of training material for the QC Microbiology Laboratory personnel
* Supporting and leading microbial method validation and development of routine testing strategies
* You will perform additional duties at the request of your direct manager
Sustaining Operations:
* Performing QC microbiology routine testing, environmental monitoring, water monitoring, and testing including sterility, endotoxin, bioburden, Biological Indicators, Growth promotion, and routine microbial identification strategies
* Routine monitoring of laboratory KPIs, stock control of laboratory consumables and reagents, and support for future expansion/upgrade projects
* Supporting the QC Senior scientist in OOS, OOL, microbial contamination, adverse trends, utility, and environmental excursion investigations, change controls, and CAPAs tasks
Requirements:
* 5+ years' experience in a large-scale Biopharmaceutical/pharmaceutical facility
* Experience with facility start-up projects (brown field or green field) is desirable
* Previous experience in a Quality Control/GMP environment is required
* Knowledge of microbial testing and microbial control in support of biopharmaceutical manufacturing is preferred but not required
Qualifications:
* Ph.D. with/without post doc experience or MS in Microbiology or related field is desirable
* Minimum of an honours science degree in a related field with 5+ years relative experience is essential
Benefits:
* Bonus
* Life Assurance
* Paid Holidays
* Parking
* Pension
* VHI