Senior Project Engineer. Limerick. €36~€45 per hour.

Senior Project Engineer / Cell Engineer. Limerick. €36 ~€45 per hour.  

 Initial 12-month contract, onsite role. 

Responsibilities 

• 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 and Experience Required for Role 

• Hold a relevant level 8 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