Job Title: Equipment Qualification and Validation Specialist
We are currently recruiting for an exciting opportunity with a leading Pharmaceutical organization in Cork.
This role is ideal for individuals looking to join a multinational company that excels in its field.
Duties:
* Ensure the highest Quality, Compliance, and Safety standards primarily through equipment qualification, commissioning, and validation, project management, and other activities.
* Collaborate with a team to enhance the Technology Transfer group and Tech Ops performance.
* 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 in the vaccine and biopharmaceutical processing field of expertise and deploy process improvements through innovation and utilization of these technological advances.
* Contribute to driving a culture of Continuous Improvement by deploying 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 with people 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 a biopharmaceutical/vaccines environment would be advantageous.
* Degree or Master's in a Science or Engineering discipline (preferably Biotechnology).
* Prior experience with equipment commissioning, qualification, and validation.