Lyophilisation Lead Engineer – Kerry

Lyophilisation Lead Engineer – Kerry

An opportunity is now available for a Lyophilisation Lead Engineer a site based role in the Kerry area. The successful candidate will be qualified with Bachelor’s or Master’s Degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field.

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• Manage and contribute throughout project, technology transfer, and commissioning/validation activities, providing process engineering expertise and leading or supporting cross‑functional teams.
  
• Apply strong analytical, prioritisation, and project execution skills, with experience in PAT, automation, SCADA/HMI, and cycle modelling.
  
• Provide technical support to lyophilisation operations, engineering, and control systems to ensure efficient, compliant operations and achievement of project and production schedules.
  
• Ensure GMP compliance and data integrity of computerised systems, maintaining high system performance in line with site standards and regulatory expectations (FDA, EMA, ICH).
  
• Lead and support incident, deviation, and CAPA activities through effective investigation, root cause analysis, and timely implementation of corrective actions.
  
• Drive proactive problem‑solving, process optimisation, and continuous improvement initiatives using Lean Six Sigma, delivering measurable performance, cost, energy, and waste reduction benefits.
  
• Responsibilities also include training and developing staff, preparing and maintaining production SOPs and related documentation, promoting strong teamwork and a culture of safety awareness.
  
• The role ensures compliance with cGMP, ISO 14001, Health & Safety, and Environmental legislation.
  
• Supports cross‑functional compliance efforts and operates equipment as required to support lyophilisation operations.
  

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• Experience in freeze‑drying/lyophilisation projects or operations in pharma/biotech. (e.g., vial processing in Lyomax 30).
  
• Experience in a cGMP start‑up environment is preferred along with advanced technical experience including expert knowledge relating to aseptic vial lyophilisation process, including CIP, SIP & FIT.
  
• Experienced with process control systems, process instrumentation, equipment qualification, and process validation.
  
• Possesses excellent organisational, interpersonal, verbal communication and written communication skills. xcfaprz
  
• Ability to work effectively using own initiative or as a member of a team as required.