Validation Engineer – 6-Month Contract

About Your New Employer

• Join a regulated medical device manufacturing environment where quality, compliance and technical excellence are central to the operation.
• Work alongside experienced Quality and Validation professionals on critical manufacturing, equipment, facility, utility, software and computer system validation activities.
• Gain valuable experience supporting GMP compliance and regulatory standards within an established manufacturing site in Fermoy, Cork.

About Your New Job

As a Validation Engineer, you will own and support validation activities across a medical device manufacturing environment.

Your responsibilities will include:

• Managing assigned Process, Equipment, Facility, Utility, Software and Computer System Validation activities.
• Preparing Validation Plans, Protocols and Reports.
• Supporting the resolution of issues identified during validation activities.
• Ensuring a consistent validation and qualification approach across systems and projects.
• Providing guidance on the preparation and execution of validation activities.
• Maintaining the site validation system, including conducting periodic reviews.
• Participating in change control processes relating to manufacturing processes, equipment, facilities, utilities and computer systems.
• Supporting ongoing compliance with GMP, quality and industry regulatory requirements.
• Ensuring all activities are completed accurately and within agreed timelines.

This is an individual contributor role reporting to the Validation Quality Lead.

Important: You must currently live within commuting distance of Fermoy, Cork. Relocation support is not available for this position.

What Skills You Need

• A QQI Level 7 degree, preferably in Science, Electronics, Mechanical Engineering, Industrial Engineering or a related discipline.
• Experience working in a medical device manufacturing or pharmaceutical environment.
• At least one year of experience in Quality Assurance or Regulatory Affairs.
• Experience supporting or completing validation activities covering processes, equipment, facilities, utilities, software or computer systems.
• Experience with statistical analysis, Design of Experiments (DOE) and DMAIC methodologies.
• A sound understanding of problem-solving techniques and strong technical capability.
• Proficiency in Microsoft Word, PowerPoint and Excel.
• The ability to prepare standard operating procedures, training documents and regulatory responses.
• Experience using the GAMP 5 approach would be advantageous but is not essential.

What's on Offer

• A 6-month contract within a regulated medical device manufacturing environment.
• Salary of €80,000–€90,000, depending on experience.
• The opportunity to work on a broad range of validation activities across processes, equipment, facilities, utilities and computer systems.
• Valuable exposure to GMP, regulatory compliance, change control and site-wide validation systems.

What's Next

If you are a Validation Engineer with experience in a medical device or pharmaceutical environment and live within commuting distance of Fermoy, Cork, apply now to discuss this opportunity.