Are you a lead validation engineer looking for a new opportunity?
Don't hesitate and apply today!
Key Responsibilities
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.
Qualifications & Experience
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.
Key Competencies
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.
Location:
Clonmel - onsite.
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