A leading global biopharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Selling into over 100+ countries with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. Expanding heavily here in Ireland with the acquisition of several manufacturing sites, this business has invested heavily in its Biologics flagship manufacturing operation and currently require a Senior Validation Engineer.

The Role

This exciting 12-month contract role will be based in the Midlands and will be a key team member of the QC team as well as working closely with validation team. The primary role of the Validation Engineer is to validate and maintain the validated state for equipment and processes in cGxP laboratories.

Key Responsibilities would include:

• Contribute to the development of Validation Plans, Equipment Qualification Projects, Requalification Programs and Computer Systems Validation.
• Responsible for managing the timely development, execution and approval of all Laboratory validation programs and lifecycle documentation and to ensure completion of projects per schedule requirements.
• Work closely with validation contractors and quality control to generate and execute equipment qualification documents.
• Coordinate and supervise validation testing performed by vendors and validation contractors.
• Represent validation in multi-disciplinary teams focused on commissioning, validation, and computerized system validation.
• Support the Periodic Review's and revalidation program.
• Ensure site alignment with corporate standards and cGxP guidelines.

The Person

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

• Degree (L8) qualified in engineering, science, or a technical equivalent.
• 4+ years Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience.
• Validation experience with analytical lab equipment, support equipment, utility systems, computerized systems/automation, periodic reviews, cleaning and process validation.
• Thorough knowledge of global regulatory requirements for validation, including ERES (Part 11 and Annex 11) and GAMP guidelines.
• Skilled in data integrity, laboratory equipment qualification, and GCP, GLP and cGMP regulatory procedures.

What's on offer:

• Exciting long-term daily rate contract role within a leading global biopharmaceutical organisation.
• Opportunity to work within a global leader giving you access to build your portfolio within the biopharmaceutical 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.