Senior Specialist, Validation Engineer

About the Job

We are looking for passionate and experienced professionals to join our client Commissioning, Qualification, and Validation team as a Senior Validation Engineer. This role is a 12 - month contract role, with a possibility for extension. This role is based in the Dublin area. This is a great opportunity to be part of a world-class Sterile Drug Product Facility, where innovation, quality, and teamwork are at the heart of everything we do.

• Contribute to the Sterile Drug Product Facility project as an integral member of the CQV team.
• Create and implement commissioning and qualification plans for both new and existing equipment and systems.
• Conduct equipment and system start-up activities, including initial power-up, configuration, functional testing, and troubleshooting to ensure proper installation and operation in accordance with design specifications.
• Develop and execute IQ, OQ and PQ (Installation, Operational, and Performance Qualification) protocols to verify that equipment and systems are installed correctly, operate as intended, and consistently perform according to predefined specifications and regulatory requirements.
• Develop and execute validation protocols to support the qualification of facilities, utilities, equipment, and computerized systems, ensuring compliance with regulatory and quality standards.
• Ensure all validation activities are conducted in compliance with applicable regulatory requirements, including FDA, EMA, and ICH guidelines, as well as industry best practices such as GAMP 5, to maintain data integrity, product quality, and inspection readiness.
• Maintain accurate and up-to-date validation documentation to ensure audit readiness and compliance with regulatory and quality standards.
• Identify and evaluate opportunities for process improvements, implementing changes that enhance operational efficiency and ensure ongoing regulatory compliance

Qualifications and Experience Required:

• Bachelor's degree in a scientific, technical, or engineering discipline, minimum.
• Prior GMP experience is essential.
• Previous CQV experience is a distinct advantage.
• Biopharmaceutical process and validation knowledge preferred for an ideal candidate.
• Past experience working in a drug product filling facility would be preferable.