Equipment Engineer

PE Global; Limerick; On-site; EUR 40,000 - 70,000; Full time

Job summary

PE Global (UK) is seeking an engineer to provide support in developing new or improving existing equipment and processes. The role involves defining equipment requirements, safety considerations and aligning with customer needs.

You will manage small to medium scale projects, assist with budgets, evaluate technologies, and lead validations in accordance with IML procedures while interfacing with cross-functional teams. Strong QA and process improvement focus is required.

Qualifications

• Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering.
• 2–4 years’ experience in relevant engineering role.
• Experience in GMP or medical device manufacturing environments.
• Experience in equipment and process validation activities.
• Familiar with ISO safety standards.
• Knowledge of statistical techniques (ANOVA/DOE) is advantageous.

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, e.g. URS, Microsoft Project, etc.
• 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, NCRs, CAPAs, Maps, etc.)
• Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.

Skills

Project management

Communication

Analytical thinking

Team orientation

Attention to detail

Initiative

Education

Degree in production/manufacturing/mechanical engineering

Tools

Microsoft Project

URS

Job description

Job Purpose:
Provide engineering support in developing new or improving existing equipment and/or process related activities. Assist in defining process equipment requirements and specifications based on process requirements, safety requirements and customer needs.

Responsibilities:

Main areas of responsibility:

• −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

Essential:

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

Desirable:

• − 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
• − 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

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***