A leading biotechnology company with headquarters in the USA that creates life-transforming medicines for people with serious diseases are seeking to appoint a Validation Manager to be based in their Munster site. The organisation have a global headcount of around 10,000 with the Munster site an industrial operations and product supply facility.
Duties and responsibilities of the Validation Manager will include:
- Creating and implementing policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
- Developing team member and interpersonal capabilities in the areas of cleaning validation, SIP validation and continuing validation.
- Coordinating the collective efforts of other departments or outside contractors/vendors to complete validation tasks.
- Leading comprehensive technical and quality investigations.
- Reviewing and approving completed qualification and validation protocols, summary reports and associated data for conformance to regulations and SOPs
- Proactively leading deviation notifications, deviation investigations, and corrective actions
You will have skills and experience in the following:
- Degree in Science/Engineering or relevant
- 6+ years validation experience
- People management/Leadership experience
- Experience working with Global Regulatory Agencies
To learn more about this role apply online or contact Laura Gallagher on 00353 876383699 for a confidential discussion.