Looking for a Manufacturing Engineer for a 24 month contract project focussed role for a leading Medical Device company based in Athlone. The Manufacturing Engineer will be based on-site and will be part of a larger project team.
• Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Design arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Design sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapt machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develop manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensure processes and procedures are in compliance with regulations.
• Planning and execution of protocols and validations to regulatory and GAMP requirements.
• Establish and develop strong and effective working relationships at all levels to ensure maximum effectiveness.
• Manage the implementation and validation of process projects using effective project management tools and techniques.
• Co-ordinate the planning and execution of line trials, data recording and analyses and the security of line samples and resulting data.
• Provide technical back-up as required to resolve validation and process issues.
• Monitoring of materials, equipment and process flows during validation and ramp-up related activities to ensure high levels of performance and OEE.
• Engage with the appropriate personnel in the resolution of technical, quality and manufacturing issues in assigned areas where they pertain to equipment validation execution and performance.
• Risk Management – As part of a team co-ordinate the completion of Risk Management to include the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis etc. to all product groups.
• Pursue the achievement of optimum performance on a continuous basis.
• Execute root cause analyses, establish and implement optimal solutions to machine and process issues.
• Support on-going communication through reports and information transfer as needed.
Bachelor’s degree in a Science/Technology/Engineering related discipline (e.g. Electrical or Mechanical Engineering).
• Minimum 5 years relevant and recent experience in process / validation engineering in a highly regulated environment. Knowledge of GAMP5 or other Validation methodology a distinct advantage.
• Dynamic team player and leader, with the ability to work effectively and proactively on cross-functional teams
• Ability to be self-directed and to effectively interface with various levels and functions within the organization
• Results driven and dynamic team player and can work effectively and proactively on cross-functional teams.
• Proven track record in the execution of protocols and validations to FDA and Irish/European regulatory requirements.
• Successful track record of project managing validation activities and implementing capital and cost reduction projects.
• Strong competency in manufacturing processing and systems
• Sound technical engineering approach to project management and problem solving
• Organised and resourceful with excellent attention to detail and ability to get the job done
• Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and plant performance.
• Effective communicator with all levels of the organisation and interaction with customers.
• Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise.
• Excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken
If you are intersted in this Manufacturing Engineer role, please send your resume to: firstname.lastname@example.org or call me for more information on 091 455 300.
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