Job Description
We are seeking an experienced professional to join our team at a leading Pharmaceutical organization based in Cork. This is an excellent opportunity for individuals looking to work with a multinational that sets the standard in its industry.
Main Responsibilities
1. Ensure adherence to the highest standards of Quality, Compliance and Safety across all activities, primarily focusing on equipment qualification, commissioning, and validation as well as project management.
2. Collaborate with a team within the Technology Transfer group and Tech Ops to drive performance and achieve shared goals.
3. Lead the qualification of new equipment supporting vaccine manufacturing and provide technical support to the team while overseeing projects/project management.
4. Develop and execute protocols to facilitate equipment qualification and ensure compliance.
5. Conduct thorough reviews and assessments of Global Change management records as required.
6. Promote technical best practices aligned with global and local standards.
7. Stay up-to-date with the latest technological advancements in the vaccine and biopharmaceutical processing field and identify opportunities for process improvements.
8. Foster a culture of Continuous Improvement by implementing lean principles and process innovations within Tech Ops.
9. Maintain effective stakeholder relationships with decision-makers, colleagues, and cross-functional teams through trust-building and communication.
10. Participate in and comply with the Manufacturing Division Quality Management System (QMS) requirements, assuming ownership as necessary.
11. Take the lead in Knowledge Management efforts within the team.
Requirements
* Process engineering experience in biopharmaceutical/vaccines environment is advantageous.
* Bachelor's or Master's degree in a Science or Engineering discipline, preferably Biotechnology.
* Previous experience with equipment commissioning, qualification, and validation is essential.