Job Description
A Technical Specialist is required for a 12-month contracting position with our pharmaceutical client in Cork.
The Role:
* Actively lead and support process microbiological investigations.
* Perform routine area walkdowns and GEMBAs to identify areas for improvement.
* Support and drive strategy improvements related to contamination risk reduction and microbiological hygiene promotion through continuous improvement and open communication.
Responsibilities:
* Perform Risk Assessments for operations projects and business innovation initiatives.
* Define specific aseptic techniques for crucial process steps.
* Support periodic review of environmental monitoring and in-process sampling trends, and identify corrective and preventative actions as required.
* Provide effective and timely communication of adverse trends or activities.
Requirements:
* BSc in a scientific or technical discipline (microbiology preferred).
* Minimum 3-5 years of experience in a pharmaceutical or GMP regulated Operations environment.
* Knowledge and experience of the shop floor manufacturing process.
* Knowledge of data analytics.
* Familiarity with FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.