Lyophilization Lead Engineer (Permanent)Tralee, IrelandResponsibilities:• Lead 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.Requirements:• Proven 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.