PE Global is currently recruiting for a Project Engineer for a leading multi-national Med Device client based in. This is an initial 12-month contract position.
ROLE:
- Provide engineering support in developing new or improving existing equipment and/or process related activities Primary Tasks and Responsibilities
- Define or assist in defining process equipment requirements and specifications based on process requirements, safety requirements and customer needs
- 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 recognized 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 utilizing the NCMR and CAPA processes
REQUIREMENTS:
- 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
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up-to-date CV to sean.molloy@peglobal.net ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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