Lyophilization Lead Engineer (Permanent) Tralee, IrelandResponsibilitiesLead process engineering support across tech transfer, commissioning & validation activities.Provide SME support for lyophilisation operations, engineering & control systems to meet production schedules.Ensure GMP compliance and data integrity for computerized systems (FDA/EMA/ICH expectations).Drive investigations (deviations/CAPA) and continuous improvement using Lean Six Sigma.RequirementsProven experience in freeze-drying/lyophilisation within pharma or biotech (vial processing ideal).Strong expertise in aseptic vial lyophilisation including CIP, SIP & FIT, plus validation/qualification.Bachelor’s or Master’s degree in a relevant engineering/science discipline.
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