FEA Engineer: GMP Equipment & Process Validation

PE Global; Limerick; On-site; EUR 52,000 - 74,000; Full time

Job summary

PE Global is recruiting a Finite Element Analysis Engineer for a leading multinational client based in Limerick. This onsite, 12-month contract role focuses on supporting equipment/process development, validation activities, and continuous improvement within a GMP/medical device manufacturing environment.

The candidate will contribute to root-cause analysis, process optimization, and cross-functional collaboration, applying analytical techniques and project management skills to deliver

Qualifications

• Requires a relevant degree in production, manufacturing or mechanical engineering.
• 2–4 years' experience in a relevant engineering 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.
• 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 project tools to manage projects successfully.
• Develop equipment, process and product knowledge to be recognised as a local expert.
• Measure/evaluate equipment efficiencies and downtime and assist in maintenance development.
• Propose and implement improvement projects to improve compliance, efficiency, yields or throughputs.
• Define root cause and implement solutions to non-conformances using NCMR and CAPA processes.
• Interface with cross-functional teams and support day-to-day operating requirements.
• Implement safety/environment requirements on purchases and changes of equipment.

Skills

Analytical thinking

Project management

Problem solving

Statistical methods (ANOVA)

Communication

Education

Bachelor's degree in Mechanical/Production/Manufacturing

Tools

URS

Microsoft Project

Job description

PE Global is recruiting a Finite Element Analysis Engineer for a leading multinational client based in Limerick. This onsite, 12-month contract role focuses on supporting equipment/process development, validation activities, and continuous improvement within a GMP/medical device manufacturing environment.

The candidate will contribute to root-cause analysis, process optimization, and cross-functional collaboration, applying analytical techniques and project management skills to deliver