Job Description
Job Summary: Solution focused, diagnosing and implementing permanent solutions to manufacturing issues in a structured problem-solving approach. Championing problem solving through appropriate documentation and knowledge sharing. Drive Continuous Improvement by leading the implementation of Lean/Six Sigma manufacturing principles. Work within a highly regulated environment ensuring highest product quality is achieved through robust quality system processes such as GMP, NCR and CAPA. Improve the production flow to achieve quality at source, rapid feedback from inspections. Ensure product specification requirements are met and inspection standards are met through concise standard work. Lead teams in the execution of validation activities. Analyze and implement innovative improvements in operational performance through key Overall Equipment Effectiveness (OEE) metrics Yield, Uptime and Performance. Increase capability, capacity and stability of processes, product, equipment and materials. Mechanical design of jigs and fixtures to meet manufacturing requirements, optimize machine changeover time and improve maintenance. Evaluate new equipment/processes/chemicals for environmental impact. Adhere to Plant Safety requirements and Health & Safety requirements relating to your work. Be aware of potential environmental impacts associated with your work. Contribute to enhanced energy performance by conservation of energy. Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems.
Responsibilities:
* Champion problem solving through documentation and knowledge sharing.
* Drive Continuous Improvement through Lean/Six Sigma manufacturing principles.
* Work within a highly regulated environment to ensure highest product quality.
* Improve production flow to achieve quality at source.
* Lead teams in the execution of validation activities.
* Analyze and implement improvements in operational performance through OEE metrics.
* Increase capability, capacity and stability of processes, product, equipment and materials.
* Design jigs and fixtures to meet manufacturing requirements.
* Evaluate new equipment/processes/chemicals for environmental impact.
* Adhere to Plant Safety and Health & Safety requirements.
* Contribute to enhanced energy performance.
Requirements:
* Knowledge/experience of validation techniques & applications (IQ/OQ/PQ, TMVs etc.).
* Associated regulatory requirements and statistical data analysis.
* Motivated & flexible approach to work with results-oriented attitude.
* Excellent interpersonal, communication, planning and organizational skills.
* Ability to manage complex technical projects through Project Management methods and tools.
* Influential and motivated team member.
* Provides technical guidance & mentorship of technicians.
* NFQ Level 8 in a Technical Discipline (Mechanical, Manufacturing, Mechatronics or Biomedical) with a minimum of two years relevant industry experience.
* Project Management and Six Sigma qualifications will be a distinct advantage.