We’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This position will be responsible for providing engineering support in developing new or improving existing equipment and/or process related activities. Define or assist in defining process equipment requirements and specifications based on process requirements, company’s safety requirements and customer needs.

Duties:

• Perform project management tasks for small to medium scale projects involving either new or existing equipment
• Assist in determining the budget to support requirements
• Evaluate or assist in evaluating technology necessary to support requirements
• Propose options to Management/Customer/Stakeholders
• Provide technical support for projects
• Support and/or develop and execute equipment or process related validations in accordance with IML requirements, processes and procedures
• Assist in negotiation with equipment suppliers
• Utilize necessary project tools, i.e. URS, Microsoft Project, etc. to manage projects successfully
• Develop the necessary equipment, process and product knowledge to be recognised as a local expert.
• Measure/evaluate equipment efficiencies, downtime and assist in the development of maintenance requirements
• Propose and implement improvement projects that improve compliance, improve efficiencies, yields or throughputs
• Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes.
• Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements
• Ensure effective closure on quality system documents (Audit Action, NCR’s, CAPA’s, Maps, etc.)
• Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.

• Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering.
• 3 years’ minimum experience in a Manufacturing or Project Engineer role from a GMP regulated environment.
• Prior experience in equipment and process validation activities
• Process development experience
• Familiar with ISO safety standards
• Previous experience in the use of ‘black belt’ statistical techniques would be a distinct advantage, as would familiarity with equipment validation in a FDA environment
• Have statistical process control and capability analysis using ANOVA and DOE techniques
• Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential requirement.