Validation / Process Development Engineer
4 weeks ago
This engineer will use the required engineering competencies and systems training to support the automation project.
ResponsibilitiesResponsible for managing and delivering key project tasks assignedWork with automation vendor, 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 milestonesSupport the project team where required in delivering a world class automation projectReview 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 beneficialSelf-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environmentThe individual should enjoy working in a fast paced, dynamic and results orientated project team environmentInnovative thinker - able to envisage new and better ways of doing thingsStrong communication and influencing skills with internal and external agentsCapable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environmentDemonstrable analytical & problem solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environmentExperience in an FDA regulated or regulated industry beneficialExcellent presentation and written / verbal communication skillsDemonstrable ability to work autonomouslyA team player, with a flexible approachTechnological pioneer, willing to source, investigate and implement technological and automation advancesConfident and effective decision maker, with a proven leadership ability to negotiate and influence others.
BenefitsCompetitive and attractive employee compensation packagePension contributionsHealth insurancePaid public holidays Location: Limerick, Ireland | onsite
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