The role:PE Global is currently recruiting for a Senior Validation Engineer on behalf of a leading pharmaceutical company based in Sligo. This is an initial 6-month contract role.Purpose:To coordinate the development and maintenance of the company's validation program in compliance with all applicable regulatory and company requirements. Co-ordination, implementation and active participation in the site Validation Program.Responsibilities:Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.Generation/maintenance of the Validation Master Plans.Generation/maintenance of Project Validation Plans.Generation of validation plans, protocols and final reports to cGMP standard.Understanding of Risk based equipment qualification, Equipment Risk Assessments, Critical Elements Test Plan developmentReview / approval of all protocols and final reports.Management of validation change control process.Adheres to and supports all EHS & E standards, procedures and policiesEducation and Experience:3rd level qualification in a relevant engineering or scientific discipline.A minimum of 5-10 years' experience in a cGMP regulated environment.A good understanding of regulatory requirements.Must have hands on experience of execution of IQ/OQ/PQ for Facilities/ Utilities/ Equipment in Pharmaceuticals or Medical Devices or DiagnosticsAdheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.Individual is fully responsible for the co-ordination and closure of projects assigned.Close contact with internal and external auditors, e.g. FDA, HPRA.Is a site SME on validation issues and provides guidance on same.Interested candidates should submit an updated CV.Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***