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PROJECT VALIDATION ENGINEER
Company:CBS BUTLER |
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Job Reference Number |
14564661 |
Client ID: |
RI/RLA65740 |
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Posted On: |
Feb 2 2012 |
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Location: |
CORK, CORK |
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Job Type: |
Contract |
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Salary: |
NEGOTIABLE |
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Role:
* Conduct validation activities in compliance with US and EU regulations,
* Develop validation documentation as required (e.g. plans, protocols, reports, procedures).
* Execute validation protocols as required (e.g. Equipment IQ/OQ, Software IQ/OQ, Process OQ, Process PQ etc).
* Prioritize qualification activities in line with the project schedule
* Co-ordination, implementation and active participation in the site validation program for new products and associated process, equipment, software, methods, utilities/facilities, cleaning and sterilization.
* Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
* Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
* Resolve and assist in the closure of deviations initiated during qualification / validation execution.
* Initiate and implement change control activities in accordance with site procedures. .
* Generate procedures / other documentation as applicable.
* Conduct training in validation methodologies and related procedures as required.
* Present validation systems at internal and external audits.
* Relevant 3rd Level Qualification in science, technology or engineering (degree preferable, but suitable industry experience with lesser qualification can be accommodated).
* 5 years experience in a validation related role.
Medical Device experience within a high volume-manufacturing environment desirable.
* Working as part of an integrated new product team, the Project Engineer - Validation will have a proven record of validation expertise within a regulated environment. Experience preference is 1.) Medical Device Manufacturing and 2).Pharmaceutical/Bio-Pharma.
* Industry Experience of 5 years minimum in Validation related activities is required.
o Experience in CNC machining processes would be an added advantage.
* The Project Engineer - Validation will bring specific experience and knowledge of FDA and ISO requirement relating to Validation Program requirements and Validation Documentation Practices, with specific area knowledge in:
o Process Validation / Test Method Validation (this role requires process development capabilities also)
o Equipment Qualification / Computer Systems Validation
o Cleaning Validation / Sterilisation Validation
* Excellent interpersonal skills
* Excellent communication skills both written and verbal
* Self Starter / Team Player / Minimal Supervision
* Excellent analytical and reporting capabilities, with a preference for expansive knowledge of Minitab Release 15 for Process Validation Engineers.
* Must be able to generate, follow and explain detailed quality and validation requirements.
* Must be able to plan, organize, and implement multiple concurrent tasks.
* Blueprint/Engineering schematic reading and interpretation.
* Intermediate PC skills.
