Technical Specialist - Process Support

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Ensure the highest Quality, Compliance and Safety standards primarily with equipment qualification, commissioning and validation, project management but relating to all activities.
• Work within a team to enable the team’s performance within the Technology Transfer group and Tech Ops.
• Responsible for the qualification of new equipment to support vaccine manufacturing, providing technical support to the team and leading projects/project management.
• Development and execution of protocols to support equipment qualification.
• Technical Review, ownership of and impact assessment of Global Change management records as required.
• Recommend technical approaches in line with global and local standards.
• Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
• Contribute for driving a culture of Continuous Improvement by deploying MPS within Tech Ops on projects such as: problem solving, reducing cycle time, Lean principles within the new processes.
• Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on 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.

• Process engineering experience in biopharmaceutical/vaccines environment would be an advantage.
• Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
• Prior experience with equipment commissioning, qualification, and validation.