The role is to provide engineering support for manufacturing operations based within the value streams. The role requires technical ownership to be taken for a number of process steps and contributing towards key business drivers such as HSE, Quality, Supply and Cost. The role will also require a focus on process stability which will involve managing CAPA and CIP projects. As process owner the role will involve collaborating with a number of functional groups delivering projects in the value stream such as NPI and Manufacturing Engineering as well as with suppliers and other sister sites running similar processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Support attainment of key business metrics through the provision of engineering support for value stream processes
- Elimination of safety and quality risks in the process through the delivery of robust engineering solutions.
- Manage costs through the delivery of scrap, reprocessing and consumable projects.
- Design & develop tools, fixtures, gauges and special equipment for manufacturing operations in conjunction with Toolroom Technicians and outside vendors.
- Develop stable and capable manufacturing processes through a structured process development approach.
- Preparation of all relevant manufacturing specifications
- Actively promote a safety culture
- Ensure production equipment meets all relevant national and J&J Health, Safety and Environment requirements through completion of required assessments and documentation
- Competent in validation requirements for new consumables / materials and process changes.
- Creation of validation documents (like IQ,OQ,PQ)
- Updates and maintenance of manufacturing specifications for process steps.
- Ensure timely closure of quality actions such as Audit Actions, NCR’s, CAPA’s. Ensure all process development, validation, etc. is managed in accordance with the Quality management system
- Support day to day operations through attendance at pulse walks and the timely closure of actions.
- Root Cause Analysis and implementation of robust solutions to supply and quality issues as they arise through tools such as 8D and Six Sigma.
- Lead scrap reduction within the value stream through a structured approach to data capture, analysis and problem solving.
- Identify and lead cost and technical improvements under the department’s continuous improvement program.
- Provide process input into the value stream mapping process which is used to develop the business plan for the value stream.
- Support the implementation of all engineering and plant strategic initiatives.
- Bachelor Degree in Engineering
- Knowledge of Process Validation
- Knowledge of CAPA and NC Investigations, Complaints Investigations
- Knowledge of ISO 13485 norm
- 2+ years of relevant working experience
- Experience in regulated industry environment like medical devices would be a plus
- Very good command of English is mandatory
- German skills would be a plus