IT Validation Engineer

IT VALIDATION ENGINEER LIMERICK

My client based in Limerick has an opening for an experienced I.T. Validation Engineer, has embarked on an exciting new manufacturing venture which is now under way. This new plant is part of the organisations’ expansion into a new product line which will be manufactured within an aseptic environment.

RESPONSIBILITIES OF THE ROLE WILL INCLUDE:
• Co-ordination, implementation and active participation in the site validation programme for computer systems and cleaning
• Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
• 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 and prepare reports of executed protocols
• Develop validation documentation as required (e.g. specifications, plans, protocols, procedures etc.).
• Resolve and assist in the closure of deviation initiated during qualification execution
• Initiate and implement change control activities in accordance with site procedures
• Co-ordinate re-validation activities and generate SOP’s / other documentation as applicable
• Conduct training in validation methodologies and related procedures as required.
• Present validation systems at internal and external audits and support quality assurance programmes
• Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.

SKILLS AND EXPERIENCE:
• Relevant 3rd Level Qualification in science or engineering
• Ideally 3 – 5 years IT validation experience in an established QA function preferably in the healthcare industry
• Strong knowledge of CSV/GAMP,21CFR Part 11,Project Life Cycle and cGMP Regulations,
• Cleaning validation experience would be an advantage
• Strong statistical skills and process capability are required along with excellent interpersonal, communication, facilitation and team working skills.