We are looking for a Validation Engineer to join a Pharmaceutical Company in Tipperary. This is a 12 month hourly rate contract position.
Requirements:
- Providing comprehensive lifecycle validation support across diverse site areas, including manufacturing equipment, utilities, facilities, and automated systems.
- Authoring, reviewing, and executing lifecycle documentation, including Validation Master Plans (VMPs), Risk Assessments, IQ/OQ/PQ protocols, and summary reports.
- Leading tech transfers and new equipment introductions by collaborating with cross-functional project teams from conceptual design through to routine commercial production.
- Managing vendors and third-party engineering contractors, ensuring all deliverables align with global corporate policies and site quality standards.
- Investigating validation deviations, conducting thorough root-cause analysis (RCA), and implementing robust Corrective and Preventive Actions (CAPAs) to minimize project delays.
- Supporting regular internal quality reviews and regulatory health authority inspections (e.g., HPRA, FDA) by serving as a technical subject matter expert for validation data.
Skill, Attributes, Experience:
- Minimum 3+ years experience in Validation with a background in Pharmaceuticals or Medical Device.
- Bachelor's Degree in Engineering or a related technical field.
- Proven track record in assembly validation and calibration processes.
- Strong project management skills.
- Strong communication skills.
