Process Microbiologist Cork

Fantastic opportunity available for a Process Microbiologist in the Cork area for a very busy Biopharmaceutical company in Cork.

The Process microbiologist is responsible for Active participation in the microbiological control and assurance program within the operations department.

The responsibilities & the impact YOU will have:

• Lead by example and striving to perform to high standards at all times
• Perform all activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
• Actively lead / support process microbiological investigations.
• Perform routine area walkdowns / GEMBA’s.
• Support and drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of a culture of continuous improvement and open communication.
• Perform Risk Assessments for operations projects and business innovation initiatives
• Define specific aseptic techniques to be performed for crucial process steps
• Support periodic review of environmental monitoring and in-process sampling trends and identifies appropriate corrective and preventative actions as required.
• Provide effective and timely communication of any adverse trends or activities as appropriate.
• Achieve individual goals through actively working with departments and individuals
• Maintain customer focus to deliver business requirements.
• Collaborate with Process Microbiologists
• Access global microbiology support resources, as required.
• Review and approve relevant SOP’s and WI’s.
• Participate in the planning for future requirements in Operations.
• Ensure microbiological control strategy is consistent with GMP requirements and company requirements.
• Participate in relevant internal and external manufacturing related audits.
• Understand and support current regulatory trends and future testing requirements.
• Deputize for the Microbiology team, as required
• Comply with EHS rules and procedures at all times.

• BSc in a scientific/technical discipline required. Ideally microbiology discipline
• Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
• Possess knowledge and experience of the shop floor manufacturing process.
• Possess knowledge of data analytics
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.