Posted: 18 June
The role
Manufacturing Engineer – Clonmel (Hybrid)
About the role
Our Cork based client is recruiting a Manufacturing Engineer for a hybrid working opportunity in a thriving medical devices company. The role involves working within the pharmaceutical quality system supporting commercial production of our pharma product. The successful candidate will be responsible for daily support of equipment, processes, and materials to achieve production goals, develop and implement manufacturing business improvement projects, and work with automated equipment. The role is heavily involved with equipment line moves, equipment validation, equipment qualification, process improvements, and line upgrades.
Responsibilities
Responsible for the introduction and validation of new equipment.
Analyze process, product, material or equipment specifications and performance requirements.
Work with cross‑functional teams to identify and resolve production/engineering issues.
Summarise, analyze, and draw conclusions from test results leading to effective technical resolution.
Transfer and validate equipment from one clean room to another.
Continuous improvement and yield analysis.
Continually seek to drive improvements in process equipment design, layout and operational performance.
Engage with technicians, operators, and other cross‑functional teams to ensure business process success.
Contribution to NPI (New Product Introduction) development.
Root cause analysis using Lean tools and techniques.
Write and improve process procedures.
PCA (Process Change Analysis) from documentation to implementation.
Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements.
Actively promote and participate in a cross‑functional teamwork environment.
Evaluate with EHS new equipment/processes/chemicals for environmental impact to eliminate or lessen such impacts.
Give technical guidance to associate engineers and technicians.
Understand and comply with all regulations governing the quality systems.
Ensure all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements, and that they understand and comply with all other regulations governing their work.
Qualifications and Experience
NFQ Level 8 in a technical discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
Minimum 2–5 years’ experience at an engineering level, ideally in the medical device industry or other highly regulated environment.
Experience with automated manufacturing equipment is advantageous.
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