Job Title: Process Specialist
About the Role
We are currently recruiting for an exciting opportunity with a leading Pharmaceutical organization based in Cork. This is an excellent position for anyone who wants to join a multinational company renowned for its excellence.
Key Responsibilities
* 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.
Specific Duties:
* Perform routine area walkdowns.
* Support and drive process improvements related to the reduction of contamination risks and the improvement of microbiological practices.
* Foster and promote a contamination awareness culture through open and inclusive communication.
* 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.
* Design and deliver training to support the site contamination control program.
* Support and consult from a micro control perspective on capital project initiatives.
* Maintain customer focus to deliver business requirements.
* Collaborate with Operations Process Microbiologists (internal and at platform level), wider Operations team and cross functionally to achieve business goals.
* Participate in the planning for future requirements in Operations.
* Participate in relevant internal and external manufacturing related audits.
* Understand and support current regulatory trends and future testing requirements.
* Deputize for Plant Microbiologist, as required.
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.
* Possess knowledge and experience of the shop floor manufacturing process.
* Previous experience with Project Management.