Validation Engineer

2 weeks ago

Cork, Ireland Oxford Global Resources Full time

Job Description Our client are seeking an experienced engineer who can provide advanced technical and engineering support for upcoming projects in their manufacturing division. This engineer will use the required engineering competencies to support their team. ResponsibilitiesResponsible for managing and delivering key project tasks assignedWork with automation vendors, engineering, and other functions in delivering key project task assignedActively interfacing with cross-functional team members and vendors, and always practicing good teamwork in support of the project requirements in pursuit of achieving project milestonesReview and support vendor documentation such FDS, SDS, electrical/pneumatic drawings, training material, commission reports etc and other documents as requiredGenerate, review, and approve project validation documentation URS, PFMEA's FAT, SAT, VP, IQ, OQ, PQ, reports, procedures, and other documents as required compliant with current Good Manufacturing Practices (GMP)Provide technical guidance in the machine hardware/software design/functionality to the vendor and project teamAttend and execute the automation system pre-FAT and FAT execution at vendor's siteExecute validation qualification test protocols documentsSupport debugging the automated system with structured problem solving and providing feedback to the project team and vendorSupport install of the automation system at the site in readiness for qualificationObserving the Quality Management Systems requirements on site at all timesAdherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site. RequirementsLevel 8 Degree in Mechanical EngineeringHas 2-4 years' experience in a manufacturing environmentSoftware knowledge would be beneficialExperience in an FDA regulated or regulated industry beneficialValidation ownership experience for equipment and processes

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