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.
