Equipment Engineer

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