An expanding Biotech company who are committed to partnering with leading institutions around the world, to deepen their understanding of diseases and their progression, are currently looking for a Validation Specialist.

The Role

This exciting contract role where the successful candidate will play a key role in providing hands on technical support and oversight to Qualification and Validation activities of the Manufacturing facility and Laboratories, ensuring that processes and equipment are appropriately validated and qualified in accordance with applicable Irish, EU and FDA regulations.

Key Responsibilities would include:

• Maintenance and archiving of Validation/Qualification documentation
• Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure that validation project plans are understood and in keeping with site objectives
• Review and approve validation, qualification protocols and reports
• Define and manage as system for project-related Deviations and Charge
• Maintain understanding of cGMP, Good Engineering Practices, and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities
• Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies, and reports for Quality

The Person

In order to be considered for this exciting daily rate Validation Specialist, specific requirements for the successful candidate would include:

• Qualified to Minimum of a Bachelor's degree (Level 8 NFQ) in Engineering/Science or related discipline
• Relevant experience within validations (process and equipment)
• Experience in a start-up environment that is fast paced and changeable would be an advantage

What's on offer:

• Exciting long-term daily rate contract role within an expanding company that is at the start of an exciting journey
• Opportunity to work within a biotech organisation giving you access to build your portfolio within the industry
• Potential for a long term opportunity within the organisation

To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.