Technical Process Microbiologist

Summary:

Technical Process Microbiologist

12 month contract

Cork

Job Summary

Reporting into the Plant Microbiologist, the Technical Process Microbiologist is responsible for active participation in the microbiological control and assurance program within the operations department. Managing activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.

Responsibilities

* Perform all activities in compliance with corporate, cGMP, EHS, and other regulatory requirements

* Actively lead / support process microbiological investigations and change controls

* Perform routine area walkdowns. Support and drive process improvements related to the reduction of contamination risks and the improvement of microbiological practices.

* Perform and support Risk Assessments for operations projects and business innovation initiatives

* Regular review of key performance indicators of the contamination control program Provide effective and timely communication of any emerging trends, as appropriate

Requirements

* BSc in a scientific / technical discipline required

* Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment

* Biomanufacturing possess knowledge and experience of shop floor manufacturing process is highly desirable

* Working knowledge of data analytics

* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

Please submit your CV or email me directly if you are interested in this position.

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