We are looking for a QA Validation Specialist to join a Medical Device Company in Cork. This person will be responsible for ensuring all equipment, utilities, and processes within the facility are validated and maintained in strict accordance with ISO 13485, FDA, and HPRA regulatory requirements.
This is a 12 month hourly rate contract position.
Requirements:
- Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for both clean utilities (WFI, Purified Water, Clean Steam) and standard plant utilities.
- Lead commissioning activities for new production lines, ensuring that equipment is installed and operates according to design specifications and safety standards.
- Perform FMEA and impact analyses to identify critical process parameters (CPPs) and critical quality attributes (CQAs) for new equipment.
- Author and maintain the Validation Master Plan (VMP), traceability matrices, and final validation summary reports (VSR) to ensure audit-ready documentation at all times.
Skills, Attributes, Experience:
- Bachelor's degree in Engineering, Science, or a related technical field.
- 4+ years of hands-on experience in the Pharmaceutical or Medical Device industry, specifically within a Validation or Commissioning role.
- Proven exposure to production facility environments, including experience with clean utilities (HVAC, purified water) and normal utilities.
- Effective problem-solver in validation challenges, providing practical and risk-based solutions.
- Strong communication skills as you will be partnering with Engineering, Production, and Quality teams.
