Validation Engineer - Med Devices - Athlone

Westmeath  ‐ Onsite
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Keywords

Description

My client, a leader in the world of packaging, is currently recruiting for a Temporary Validation Engineer to join their team in Athlone. Reporting to the Engineering Manager, the successful candidate will be responsible for delivering and validating projects and 'best practice' methodologies that support highly efficient processes and consistent product output to the quality satisfaction of all customers internal and external.

Responsibilities:
- Execute root cause analysis, establish and implement optimal solution to machine and process problems
- Identify process performance, efficiency and cost saving improvements and opportunities
- Define user requirement specifications for machine and process systems
- Plan and execute on purchase order documents, design reviews, FAT's, SAT's, validations, Change Development Process (CDP) and project closures
- Project manage all activities in a responsible, professional and proactive manner
- Lead teams in the planning and execution of assigned activities
- Planning and execution of Protocols and Validations to FDA requirements
- Manage the implementation and validation of assigned Projects using effective Project Management tools and techniques
- Provide technical back-up as required to resolve processing problems
- Monitoring of materials, equipment and process flows to ensure high levels of performance and OEE
- Co-ordinate the planning and execution of line trials and the security of line samples and emanating data
- Assess standard costs assigned to processes through execution of time studies and measurement of takt times and resource requirements
- Planning and execution of CAPA (Corrective And Preventative Action)
- Monitor raw materials to ensure they are to the required specification for production or packaging

Requirments:
- Bachelors degree in a Science/Technology/Engineering related discipline (e.g. Mechanical Engineering)
- Minimum 5 yrs relevant and recent experience in process / packaging / validation engineering in a highly regulated environment
- Proven track record in the execution of protocols and validations to FDA requirements in particular relating to packaging and printing processes
- Possess proven problem solving skills, CAPA, management and implementation of capital and cost saving projects
- Possess project management and execution experience demonstrating a successful track record in timely project delivery
- Significant relevant experience in Plastics technology and/or Medical Device / Pharma is a distinct advantage (3~5 years minimum)

If you feel you would be a good fit for this role please apply directly, or for immediate consideration call me, Derek Sheridan, on . Sthree UK is acting as an Employment Agency in relation to this vacancy.
Start date
12/2013
From
Real Staffing
Published at
13.12.2013
Project ID:
640487
Contract type
Permanent
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