At our Projects Engineering Department in Athlone we focus on providing stable, flexible and cost effective solutions to enhance our processes and systems that produce the highest quality products through the deployment of innovative engineering projects and solutions. Quality Engineers are directly involved in understanding and providing compliance solutions and documentation throughout the project lifecycle, designed to continuously improve our manufacturing processes, systems, quality and regulatory compliance to the highest standards.
Come for a job, stay for a career!
A DAY IN THE LIFE OF:
* Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
* Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
* Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
* Adapts machine or equipment design to factory and production conditions.
* May incorporate inspection and test requirements into the production plan.
* Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
* Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
* Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
* Ensures 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.
* Report to supervisors or management any accidents/near misses or any defects in the workplace or any infringement of any relevant Company requirements which may endanger their own safety, health and welfare of that or others
* 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.
KEY SKILLS & EXPERIENCE
* 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
A very attractive Salary/Benefits Package is on offer and negotiable
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland