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.