Overview of the rolePSC Biotech are looking for an Aseptic / Sterile experienced Manufacturing Process Specialist to join a global pharmaceutical manufacturing client in Cork. As a core member of the business unit, you will provide technical support to ensure efficient, compliant manufacturing operations in line with GMP and EHS standards.Key ResponsibilitiesDevelopment of new and revised manufacturing and cleaning recipesPreparation of scorecards, dashboards, and management review dataManagement of investigations (NCPs, complaints, EHS incidents) including RCA and CAPAManagement of manufacturing Change Control in line with site proceduresParticipation in HAZOP studies to identify and eliminate process risksIdentification of improvement opportunities through trend analysis and internal auditsDevelopment of reprocessing/rework strategies and test protocolsPartnering cross-functionally to drive innovative, practical solutionsQualificationsMinimum 5 years' experience in pharmaceutical manufacturing operations or process engineeringThird-level qualification in Engineering, Pharmaceutical Sciences, Chemistry, or similarProven experience with investigations, change control, and CAPA systemsStrong GMP knowledge and compliance mindsetExcellent communication and organisational skills; ability to meet deadlinesLEAN / Six Sigma experienceContinuous Improvement backgroundExposure to regulatory inspections (FDA, EMA, HPRA)
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