Equipment Engineer

Desired Skills: Engineering Projects,Equipment Engineering,Project Management,GMP,Root Cause Investigations,Process Engineering,MS Project

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:
− 3+ 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***

Please click the link below to apply or alternatively send an up-to-date CV to Howie at howie.leahy@peglobal.net