Validation Engineer

We are seeking a contract Validation Engineer to join our client, a leading Medical Device Company based in Cork. This is a 12 month hourly rate contract position with a January / February targeted start.

Key Responsibilities:

• Author, execute, and finalize comprehensive Validation Protocols and Reports (e.g., Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Computer System Validation (CSV)).
• Lead and execute process, system, and equipment validations (e.g., sterilization, packaging, molding, assembly) per established Validation Master Plans (VMP) and project schedules, ensuring alignment with Design Transfer requirements.
• Proactively identify continuous improvement opportunities within manufacturing processes and quality systems and lead relevant Validation/Quality system enhancement projects.
• Lead the investigation of Quality/Validation deviations using Root Cause Analysis (RCA) and implement effective Corrective and Preventative Actions (CAPA) to prevent recurrence.
• Coordinate formal Risk Management activities, including process and design Failure Modes and Effects Analysis (FMEA), to justify validation approaches.

Skills, Attributes & Experience:

• Degree in Engineering (e.g., Biomedical, Mechanical, Electrical), Life Sciences, or a closely related technical discipline.
• Minimum of 4+ years of direct experience in a dedicated Validation or Quality Engineering role within the Medical Device sector.
• Proven hands-on experience in generating and executing comprehensive validation lifecycle documents (IQ, OQ, PQ).
• Expertise in risk management tools (FMEA) and structured problem-solving (RCA/CAPA) is essential.
• Demonstrated ability to manage multiple complex projects and meet tight deadlines; strong communication and time management skills are critical.