HERO Recruitment

Validation Engineer (Med Device Cleanroom) (BB-3D68F)

Found in: Neuvoo Irlanda

Cleanroom Validation EngineerMy client is Waterford based Medical Device company with exceptions growth opportunity within the organisation! I'm pleased to be offering a new role for an experience Medical Device Cleanroom Validation Engineer to join on a permanent basis.Duties of the role:Serve as a subject-matter expert on validation activities during regulatory agency inspectionsSupport NPI team in the execution of Performance Qualification (PQ) for clean room processes as per the project schedule.Involved with conducting investigations into non-conformances and customer complaints, performing internal audits, preparing SOP's and templates, assisting in Validations and troubleshooting Quality issues.Responsible for planning and execution of Periodic Review and Revalidation activities for clean utilities, systems and equipment.Support deviation investigations throughout the manufacturing site.Manage several projects simultaneously and coordinate multiple, changing deadlinesParticipate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up related CAPA's as required.Create concise and accurate on-time technical reports. Clearly communicate results internally and to customer through the use of quality tools and statistical techniques.SME for appropriate statistical techniques to monitor process performance such as SPC, Cp, Cpk, R&R analysis, sampling techniques and other statistical techniques.Creates and evaluates metrics to drive tangible quality improvement through the team.Requirements of the successful candidate: Degree in Engineering; Mechanical/Manufacturing/Process or similar5 years' experience in Validation Engineering; Exposure to SPC and validationsKnowledge of Reg requirements ISO (phone number removed) CFR 820 is essentialKnowledge of cleanroom environmental monitoringKnowledge of ISO 31000 & ISO14644Experience in the use of techniques such as Design of Experiments, Gauge R&R, Test Method Validation, sample size justification to support design changes, validations, deviationsFor further information on this Validation Engineer role, please contact Marchon Monroe on (phone number removed)/ Check out all our open jobs on our HERO Recruitment website

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location_onWaterford, Ireland

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