Job Title: Microbiologist
Description:
We are seeking a highly skilled Microbiologist to join our team. As a key member of our team, you will be responsible for ensuring microbiological and sterility testing is performed in accordance with procedures and specifications.
* You will be involved in all aspects concerning the microbial quality of the product, such as process validation, cleaning validation, method validation/transfer, environmental monitoring, critical site utilities & services, aseptic manufacture.
Duties:
* You will support the QC Micro Team leader on day-to-day testing operations.
* You will perform Data and QC Investigations review and approval.
* You will review Specifications and plans for associated LIMS scheduling.
* You will review and approve Nonconformances, CAPA's and Change Control records.
* You will plan and oversee lab related projects, i.e., Method transfer and optimisation, Equipment Qualification etc.
* You will proactively identify and drive lab process improvements.
* You will train laboratory team on specific microbiological technology.
* You will provide superior technical support on specific microbiological technology.
* You will support lean initiatives in lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
* You will present technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors.
* You will write, review and approve technical documents e.g. protocols, APRs, specifications, filing documents.
* You will keep abreast of microbiological technology and compliance trends.
* You will work closely with the QC Micro Team Leader to identify, record and resolve any microbiology related product Quality Issues.
* You will liaise with other departments in developing & maintaining the site environmental monitoring and critical utilities programmes.
* You will support the Aseptic Manufacturing facility including but not limited to routine manufacturing operations, isolator operations, autoclave operations, gamma irradiation, CIP (Clean In Place) and SIP (Steam In Place).
Requirements:
* You must have a primary degree in a Microbiology/Science discipline with a minimum of 5 years' experience within the Pharmaceutical Industry or relevant experience as a Microbiologist.
* You must demonstrate knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities applicable to pharmaceuticals and aseptic products.
* You must have experience of managing project groups or leading teams.
* You must have experience with Microbiological technologies and methods.
* You must be an expert in a wide variety of analytical techniques including but not limited to sterility testing, bioburden and endotoxin techniques, autoclave, environmental and utilities testing, and gamma irradiation.
* You must be knowledgeable of FDA/EMEA regulatory requirements