Lyophilization Lead Engineer (Permanent) Tralee, Ireland Responsibilities 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.
#J-18808-Ljbffr