
Senior Manufacturing Engineer
- Clonmel, Co Tipperary
- Permanent
- Full-time
- 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.
- Honours Bachelor’s degree in Mechanical, Manufacturing, or Biomedical Engineering.
- 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.
- Structured onboarding and mentorship from experienced team members.
- Opportunities for professional development and cross-functional exposure.
- A supportive and innovative work culture focused on quality and impact.
- Competitive salary and benefits package