Senior Project Engineer

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]