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Cork
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Limerick
Equipment Project Engineer
| Reference: | JSC00015101 | Location: |
Limerick |
| Qualification: | Degree | Experience: | See description |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
We’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Responsibilities.
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, safety requirements and customer needs
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.
Required Knowledge and Experience:
− Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering.
− 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.
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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