We are seeking a contract Senior 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:
- 6+ years of experience in Engineering or Validation, coupled with a third-level technical qualification (or equivalent) in Engineering.
- Minimum of 6+ years of direct experience in a dedicated Validation or Quality Engineering role ideally 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.
