Technical Specialist
A highly skilled Technical Specialist is required for our pharmaceutical client in Cork, Ireland. This 12-month contracting position involves leading and supporting microbiological investigations, process improvements, and regulatory compliance.
The Role:
* Lead and support process microbiological investigations to ensure contamination risks are minimized and microbiological hygiene is maintained.
* Perform routine area walkdowns and GEMBAs to identify areas for improvement.
* Drive strategy improvements through the promotion of a culture of 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 implement corrective and preventative actions as needed.
* Provide effective and timely communication of any adverse trends or activities.
* Maintain customer focus to deliver business requirements.
* Collaborate with Process Microbiologists internally and across the network.
Requirements:
* BSc in a scientific/technical discipline (preferably microbiology).
* Minimum 3-5 years of experience in a pharmaceutical or GMP regulated Operations environment.
* Knowledge and experience of the shop floor manufacturing process.
* Data analytics knowledge.
* Familiarity with FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.