Engineering Technical Lead
1 month ago
Engineering Technical Lead
Our client, a leader in the Healthcare sector, is currently recruiting for an Engineering Technical Lead to work in the production area of their Galway manufacturing site.
The successful candidate will report to the Operations Manager.
This role is based in East Galway and is onsite.
Responsibilities :
- Liaise with the Production Manager in coordinating weekly and monthly production plans to optimize efficiencies for each production line.
- Co-ordinate technical staff and workloads during daily validation activities and new process or equipment introduction.
- Hands on atequipment to gain further understanding of equipment challenges.
- Thorough understanding of equipment on-site to make effective decision.
- Managing equipment proposals, upgrades, and co-ordination on site visits.
- Provide strong technical support on process/product technologies to support production.
- Continuous improvement focus: demonstrating strong knowledge of Six Sigma methodologies and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
- Demonstrate strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of 'waste' process steps and development of efficient, cost-effective equipment and processes.
- Work with the site EHS leader on implementing all aspects of Health & Safety requirements as well as new projects & initiatives.
- Root cause and problem solve production issues for Manufacturing Machines.
- Own and complete CAPA’s and NCMR’s related to production issues.
- Liaise with Engineering team and external equipment/tooling/material vendors in the selection,
- Co-ordinate the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
- Complete / lead the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
- Lead the technical team by maintaining an inclusive culture to meet production KPI’s.
- Determine appropriate staff levels, schedules and resources while managing the team.
- Understands and complies with all the regulations governing the quality systems.
Requirements
- Degree/Diploma in a Science/Engineering/Manufacturing discipline essential.
- 3+ years’ experience in leading technical projects, preferably in a Pharmaceutical/Medical device company.
- Experience in the introduction of new equipment.
- Lean/Six Sigma qualifications.
- Knowledge and Experience with working on Automation systems.
- Experience of maintenance management and creating maintenance plans on production equipment.
- Good knowledge of ISO 13485, ISO14001 and other ISO standards.
For more information, please contact daire.cullivan@cpl.ie
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