We are currently seeking an exceptional individual to join our Pharmaceutical organization in Cork. This is a fantastic opportunity for someone looking to work with a leading multinational company.
Duties
* Ensure the highest standards of quality, compliance, and safety across all activities, primarily through equipment qualification, commissioning, and validation, as well as project management.
* Collaborate with a team to optimize the performance of the Technology Transfer group and Tech Ops.
* Be responsible for qualifying new equipment to support vaccine manufacturing, providing technical support to the team and leading projects/project management.
* Develop and execute protocols to support equipment qualification.
* Conduct technical reviews, own and assess the impact of Global Change management records as required.
* Recommend technical approaches aligned with global and local standards.
* Benchmark and stay current with developments in new technologies within the vaccine and biopharmaceutical processing field, deploying process improvements through innovation and utilization of these technological advances.
* Contribute to driving a culture of Continuous Improvement by implementing MPS within Tech Ops on projects such as problem solving, reducing cycle time, Lean principles within new processes.
* Manage stakeholders, including multiple decision makers, corporate colleagues, and cross-functional teams, by demonstrating the ability to maintain and strengthen trust relationships at all levels.
* Participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership as relevant.
* Lead Knowledge Management efforts within the team.
Education & Experience
* Process engineering experience in biopharmaceutical/vaccines environment would be advantageous.
* Degree or Masters in a Science or Engineering discipline, preferably Biotechnology.
* Prior experience with equipment commissioning, qualification, and validation.