In partnership with its client, Kenny-Whelan is currently seeking a Project Validation Engineer to work for their client in the Co. Cork area. The Project Engineer - Validation will be a member of the R&D Team, playing a key role in the planning and execution of validation activities related to introduction of new products.

Job Responsibilities:

The Project Engineer - Validation will bring specific experience and knowledge of FDA and ISO requirement relating to Validation Program requirements and Validation Documentation Practices, with specific area knowledge in:
· Process Validation / Test Method Validation (this role requires process development capabilities also)
· Equipment Qualification / Computer Systems Validation
· Cleaning Validation / Sterilisation Validation

· Conduct validation activities in compliance with US and EU regulations, company procedures and EHS requirements.
· Develop validation documentation as required (e.g. plans, protocols, reports, procedures).
· Execute validation protocols as required (e.g. Equipment IQ/OQ, Software IQ/OQ, Process OQ, Process PQ etc).
· Prioritize qualification activities in line with the project schedule
· Co-ordination, implementation and active participation in the site validation program for new products and associated process, equipment, software, methods, utilities/facilities, cleaning and sterilization.
· 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).
· Resolve and assist in the closure of deviations initiated during qualification / validation execution.
· Initiate and implement change control activities in accordance with site procedures.
· Generate procedures / other documentation as applicable.
· Conduct training in validation methodologies and related procedures as required.
· Present validation systems at internal and external audits.

Skills, Abilities and Education

· Relevant 3rd Level Qualification in science, technology or engineering (degree preferable, but suitable industry experience with lesser qualification can be accommodated).
· 5 years experience in a validation related role.
· Medical Device experience within a high volume-manufacturing environment desirable.
· Working as part of an integrated new product team, the Project Engineer - Validation will have a proven record of validation expertise within a regulated environment. Experience preference is 1.) Medical Device Manufacturing and 2).Pharmaceutical/Bio-Pharma.
· Industry Experience of 5 years minimum in Validation related activities is required.
· Experience in CNC machining processes would be an added advantage.
· Excellent analytical and reporting capabilities, with a preference for expansive knowledge of Minitab Release 15 for Process Validation Engineers.

Kenny-Whelan Contact:

If you are interested in the above role, please send an updated CV marked for the attention of Linda Nugent, email: lnugent@kenny-whelan.ie or telephone for a confidential chat on 021-4665407