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Job ID: JOB-13269
Senior Project Engineer

Job Purpose: Short statement stating exact purpose of the role: Provide engineering support in developing new or improving existing equipment 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

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: − 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 contact Sam Nolan on 0861287244 or email consult@hero.ie to discuss further

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Sam Nolan

JOB-13269

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