Senior Validation Engineer

Role Summary:

• A new opportunity has arisen for a Senior Validation Engineer at our client’s new manufacturing facility in Co. Kilkenny.
• The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies.
• The successful candidate will be responsible to lead/supervise a team of 2 or more professionals.
• The Validation Lead will be a first level manager of a work team that could comprise professionals, technical and/or administrative staff, focusing on mentoring, coaching and coordination.

Core Duties and Responsibilities:

• Developing and evaluating quality process and system standards to ensure compliance with company standards and governmental regulatory requirements.
• Investigating/troubleshooting validation problems for equipment and/or performance processes.
• Conducting statistical analyses of testing results and process anomalies.
• Writing, reviewing, approving and/or executing documentation for new and current validation procedures and technical reports related to equipment, products and/or processes.
• May assist with establishing corporate validation policies.

Minimum Qualifications and Experience:

• Relevant third level qualification. Engineering/Manufacturing/Science is preferred.
• Minimum 5 years in the Engineering/Manufacturing/ Scientific field.
• 3-5 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
• Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
• Experience in developing projects or sites from square one will be an advantage.

Please note, we do not require agency assistance with this role.