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.

Duties

−Provide 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, safety requirements and customer needs
− 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.


Education & Experience

− Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering.
− 4 years’ experience in relevant engineering role
− Prior experience in a GMP or medical device manufacturing 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.
Other Skills and Attributes
− Develop good working relationships across the business
− Ability to motivate and lead - must be team orientated
− Ability to work on own initiative
− Good project management and communication skills.
− Attention to detail
− Supporting New Line installs / retrofits - largely providing engineering support in developing new or improving existing equipment and/or process related activities.
−Seeking relevant degree in production/manufacturing/mechanical engineering and previous experience in a GMP or medical device manufacturing environment (3-5 years).
−largely providing engineering support in developing new or improving existing equipment and/or process related activities.

For more information contact Jack Caffrey on +353873854921 [email protected]