Join an award-winning Pharmaceutical organization based in Cork as we seek a skilled professional to excel in our Technology Transfer group and Tech Ops.
This is an excellent opportunity for someone who is passionate about delivering the highest Quality, Compliance, and Safety standards in equipment qualification, commissioning, and validation, while working collaboratively with our team to drive performance.
Duties
* Ensure Quality, Compliance, and Safety standards through equipment qualification, commissioning, and validation, and project management.
* Collaborate with the Technology Transfer group and Tech Ops to achieve team performance.
* Qualify new equipment to support vaccine manufacturing, provide technical support, and lead projects/project management.
* Develop and execute protocols to support equipment qualification.
* Perform technical reviews, ownership of, and impact assessments of Global Change management records as required.
* Recommend technical approaches in line with global and local standards.
* Benchmark and stay current with development of new technologies in the vaccine and biopharmaceutical processing field, deploying process improvements through innovation and 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.
* Maintain stakeholder relationships with multiple decision-makers, corporate colleagues, and cross-functional teams.
* Participate in and comply with Manufacturing Division Quality Management System (QMS) requirements, including ownership.
* Lead Knowledge Management efforts within the team.
Education & Experience
* Process engineering experience in biopharmaceutical/vaccines environment would be beneficial.
* Degree or Masters in a Science or Engineering discipline, preferably Biotechnology.
* Prior experience with equipment commissioning, qualification, and validation.