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.

The Role

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

The Person

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.