Validation Specialist

12 hours ago

Louth Village, Ireland beBeeValidation Full time €60,000 - €90,000

Job Title: Senior Validation Engineer

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  • About the Role:">
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  • Execute qualification and validation activities for a life cycle approach following validation plans and complying with cGMP and company procedures as part of the design, build and qualification, including ongoing operations to maintain the validated state.">
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  • Author, review, execution and approval of testing protocols and reports.">
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  • Responsible for project delivery, participate on project teams, vendor enquires and the troubleshooting and monitoring of process systems.">
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  • Perform all duties in accordance with GMP requirements, SOPs and controlled documents.">
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  • Will be flexible to take on additional tasks and responsibilities as requested.">
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  • Will act as a role model for the Validation function and also the wider organization in adherence to the corporate core values.">
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  • Requirements:">
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  • A minimum of 3 - 5 years' experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT or engineering function.">
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  • Experienced in the execution of commissioning and qualification/validation of facilities, utilities, equipment and instruments (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).">
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  • Experienced in the maintenance of the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment etc.).">
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  • Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.">
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  • Experience of equipment vendor package ownership and system design coordination.">
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Contact: For further information please contact Seán McCarthy on +353 (0)87 798 8480 or *******

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