My client in Limerick are looking to recruit experienced Validation Engineers
The Validation Engineer is a member of the QA Validation team, playing a key role in the planning and execution of validation activities related to project.
Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities.
All validation activities are conducted in compliance with US and EU legislation; to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.
Primary Tasks and Responsibilities
Conduct validation activities in compliance with US and EU regulations, and EHS requirements.
Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
Execute qualification protocols as required.
Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
Prepare reports of executed protocols for review by QA.
Initiate and implement change control activities in accordance with site procedures.
Track and resolve exceptions during qualification activities.
Prioritize qualification activities in line with the project schedule.
Co-ordinate qualification activities with engineering, construction and commissioning activities.
Co-ordinate qualification activities with contractors and vendors as required.
Co-ordinate qualification document review and approval.
Collate and organize qualification files for turnover to QADC.
Attend identified training, required to fulfill the role of Validation Engineer.
Assist in the development of training material for qualification activities.
Participate in cross-functional teams as required.
Deputises for the QA Validation Manager when designated as appropriate.
Domestic and international travel may be required.![]()
The Validation Engineer is a member of the QA Validation team, playing a key role in the planning and execution of validation activities related to project.
Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities.
All validation activities are conducted in compliance with US and EU legislation; to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.
Primary Tasks and Responsibilities
Conduct validation activities in compliance with US and EU regulations, and EHS requirements.
Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
Execute qualification protocols as required.
Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
Prepare reports of executed protocols for review by QA.
Initiate and implement change control activities in accordance with site procedures.
Track and resolve exceptions during qualification activities.
Prioritize qualification activities in line with the project schedule.
Co-ordinate qualification activities with engineering, construction and commissioning activities.
Co-ordinate qualification activities with contractors and vendors as required.
Co-ordinate qualification document review and approval.
Collate and organize qualification files for turnover to QADC.
Attend identified training, required to fulfill the role of Validation Engineer.
Assist in the development of training material for qualification activities.
Participate in cross-functional teams as required.
Deputises for the QA Validation Manager when designated as appropriate.
Domestic and international travel may be required.