Project Engineer

Hero Recruitment Group; Limerick; On-site; EUR 65,000 - 85,000; Full time

Job summary

Hero Recruitment Group is seeking a Manufacturing/Project Engineer with a degree and 3+ years in a GMP environment. You will manage small to medium projects, assist in budgeting, and drive equipment/process validations. Strong cross-functional collaboration, problem-solving, and knowledge of URS/MS Project are essential.

Experience in ISO safety standards and FDA validation familiarity is advantageous. The role emphasizes teamwork, initiative and leadership to deliver compliant, high-yield

Qualifications

• Degree in production, manufacturing or mechanical engineering.
• 3+ years of experience in a manufacturing/project engineering role.
• GMP or medical device environment experience and validation knowledge.

Responsibilities

• Manage small to medium projects involving new or existing equipment.
• Assist in budgeting and evaluating technology to support requirements.
• Propose options to management and stakeholders.
• Support equipment/process validations per IML requirements and procedures.
• Interface with cross-functional teams, maintain good teamwork.
• Define root causes and implement CAPA during non-conformances.
• Use URS and MS Project to plan and track progress.

Skills

Project management

Communication

Teamwork

Initiative

Leadership

Education

Engineering degree in production/manufacturing/mechanical

Tools

URS

Microsoft Project

Job description

Degree plus 3 years min in a Manufacturing or Project Engineer role from a GMP regulated environment

1. Job Purpose:

Short statement stating exact purpose of the role:

and/or process related activities. Define or assist in defining process equipment

requirements and specifications based on process requirements, J&J safety

requirements and customer needs

2. 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 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.

3. Education and Experience Required for Role

• Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering.
• 2 - 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
• 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
• 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.