Project Engineer

Life Science Recruitment; Limerick; On-site; EUR 45,000 - 65,000; Full time

Job summary

Life Science Recruitment is seeking an Engineering/Project Engineer for an award-winning medical device organization in Limerick. You will support development and improvement of equipment and processes, defining requirements and ensuring safety standards are met.

Responsibilities include managing projects, budgets, validation activities, supplier negotiations and cross-functional collaboration to enhance productivity and compliance.

Qualifications

• 3 years minimum experience in a Manufacturing or Project Engineer role within a GMP environment.
• Experience with equipment and process validation activities.
• Familiarity with ISO safety standards.
• Knowledge of statistical techniques (ANOVA, DOE) is advantageous.
• Ability to apply a scientific approach to problem solving to maximise productivity.

Responsibilities

• Manage small- to medium-scale projects involving new or existing equipment.
• Assist in determining budget to support requirements.
• Evaluate 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 validations per GMP.
• Assist in negotiation with equipment suppliers.
• Utilise URS, Microsoft Project to manage projects successfully.
• Develop equipment, process and product knowledge to be recognised as a local expert.
• Measure/evaluate equipment efficiencies and downtime; assist maintenance planning.
• Propose and implement improvements to enhance compliance, efficiency, yields or throughput.
• Define root cause and implement CAPA solutions for non-conformances.
• Interface with cross-functional team members; uphold team collaboration.
• Implement safety/environment requirements on purchases and changes.

Skills

Problem solving

Cross-functional teamwork

Quality mindset

Analytical thinking

Education

Engineering degree in manufacturing or mechanical engineering

Tools

URS

Microsoft Project

Job description

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
• Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.

Education and Experience

• 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
• 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.