Lead Engineer

Are you a lead validation engineer looking for a new opportunity? Don't hesitate and apply today!

• 
  
• Lead engineering initiatives with a strong focus on the full equipment and systems validation lifecycle (IQ/OQ/PQ), across packaging, sterilisation, and shipping processes ensuring alignment with internal procedures and regulatory standards
  
• Evaluate, select, and implement new equipment, technologies, and processes through rigorous research, analysis, and application of engineering best practices.
  
• Manage backend operations-including packaging, sterilisation, and shipping-to meet production targets and maintain seamless supply chain performance.
  
• Drive automation and digitalisation projects to enhance operational efficiency, reliability, and compliance.
  
• Support product and process validation activities, including documentation development and execution of qualification protocols.
  
• Collaborate on new product introductions and technology transfers, ensuring smooth integration into existing manufacturing systems.
  
• Identify and lead process improvement initiatives using Lean, Six Sigma, or equivalent methodologies to reduce waste and optimise performance.
  
• Review and contribute to technical documentation, change controls, reports, and memos to support continuous improvement and knowledge transfer.
  
• Provide hands‑on technical leadership and mentorship to junior engineers and technicians, fostering a culture of learning and accountability.
  
• Ensure full compliance with GMP, FDA, BSI, EEO regulations and internal quality systems, supporting audits and inspections as required.
  
• Actively participate in cross‑functional teams, working closely with Quality, Regulatory Affairs, Operations, and Supply Chain to deliver business‑critical outcomes.
  

• 
  
• Bachelor's degree in Mechanical, Manufacturing, or Biomedical Engineering (Level 8 preferred).
  
• Minimum 5 years' experience in a regulated manufacturing environment (MedTech or pharma).
  
• Proven experience in at least two or more of the following: Packaging, Sterilisation, Shipping, Automation, Validation, Process Improvement, Product Launches.
  
• Strong understanding of GMP, validation protocols, and risk management.
  
• Hands‑on experience with equipment troubleshooting, process optimisation, and documentation.
  
• Familiarity with technical writing, including protocols, reports, and SOPs.
  

• 
  
• Excellent problem‑solving and analytical skills.
  
• Strong communication and interpersonal abilities.
  
• Collaborative mindset with a commitment to mentoring and team development.
  
• Detail‑oriented with a proactive approach to continuous improvement.
  
• Ability to manage multiple priorities in a fast‑paced, regulated environment. xcfaprz
  

Location: Clonmel - onsite.