Conor Lavelle
Mechanical Engineer, BEng (Hons), medical device manufacturing, equipment and validation
Waterfordconor.lavelle@example.com086 555 0148Summary
Mechanical Engineer with six years in regulated manufacturing, currently the equipment owner for a moulding and automated assembly line producing drug delivery components in a medical device plant. Introduced two pieces of capital equipment from user requirements to PQ, cut unplanned downtime on the line's oldest moulding cell by a third through a reliability programme, and closed every observation raised on the equipment in the last notified body audit. Comfortable on the floor with a technician and in a change control board with quality.
Experience
Mechanical Engineer, Equipment and Validation, Comeragh Medical Technologies
– Present
Waterford
- Equipment owner for a line of eight injection moulding cells and two automated assembly machines running three shifts, responsible for performance, change control and the validated state of each asset.
- Led the introduction of a €1.4 million automated assembly cell from user requirement specification through FAT at the vendor in Germany, SAT, IQ, OQ and PQ, handing it to production four weeks ahead of the plan.
- Ran a reliability programme on the oldest moulding cell, moving it to condition-based maintenance on the hydraulic and temperature control units, which reduced unplanned downtime by about a third over a year.
- Author and execute validation protocols and reports under the site's validation master plan, and present equipment changes to the change control board with the quality and regulatory functions.
- Supported a notified body audit as the equipment subject matter expert, with no findings against the assets in scope.
Project Engineer, Packaging Equipment, Suir Contract Packaging Ltd
–
Clonmel, Co. Tipperary
- Specified, procured and commissioned a serialisation and aggregation line for pharmaceutical secondary packaging, including the mechanical integration of the vision and labelling units.
- Redesigned the changeover tooling on two cartoning machines in SolidWorks, bringing the average changeover down from over an hour to under twenty minutes.
- Maintained the site's equipment drawings and spare parts lists in the computerised maintenance management system.
Education
BEng (Hons) Mechanical Engineering
South Eastern Technological Institute, Waterford
Engineers Ireland accredited. Final year project on cooling channel design for injection mould tooling, sponsored by a local moulding company.
Skills
- Injection moulding and automated assembly equipment
- Equipment validation (URS, FAT, SAT, IQ, OQ, PQ)
- GMP, change control and deviation investigation
- Reliability and planned maintenance
- Root cause analysis (5 Whys, fishbone, FMEA)
- SolidWorks and GD&T
- Capital equipment projects and vendor management
- Lean tools: SMED, OEE, 5S
- Computerised maintenance management systems
- Safety, health and welfare at work regulations and machinery directive
- Technical writing for protocols and reports
Certifications
- Associate Member, Engineers Ireland,
- Lean Six Sigma Green Belt, Irish Centre for Business Excellence,
- Machinery Safety and CE Marking training, Engineers Ireland,