Summary:Our client, a biopharmaceutical company located in Louth, is seeking aTechnical Support Specialistto provide technical leadership within Drug Product manufacturing. The ideal candidate will support formulation, filling, lyophilisation, capping and automated visual inspection operations, and will work closely with cross functional teams to support commercial manufacturing, new product introductions, equipment qualification and continuous improvement activity.Responsibilities:Provide technical leadership and SME support across DP operations including formulation, filling, lyophilisation, capping and automated visual inspectionCoordinate technical deliverables to support successful product launch activityProvide technical oversight and support to commercial manufacturing operationsLead or participate in manufacturing investigations to ensure robust root cause analysis and implementation of CAPAsSupport Batch Disposition activities through provision of technical commentary resolutionIdentify and implement continuous improvement projects to enhance compliance and manufacturing capabilitySupport Lean Six Sigma deployment within DP operationsCreate and revise technical documentation including MBRs, SOPs and technical memosAct as technical point of contact during audits and inspectionsSupport execution of equipment qualification activities including FAT, SAT, IQ and OQAct as delegate for the Manufacturing Technical Lead as requiredQualifications & Experience:Bachelor's degree in Engineering or Science related discipline required3 plus years' experience in biopharmaceutical, pharmaceutical or vaccine manufacturingPrevious sterile manufacturing experience preferredExperience in equipment qualification activities (FAT, SAT, IQ, OQ)Strong experience in leading complex technical investigationsExperience applying risk-based tools such as FMEALean Six Sigma experience