Cleaning Validation Expert
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Join our Biopharmaceutical organization based in Carlow for an exciting opportunity.
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We are currently recruiting for a Hybrid role in Cleaning Validation. This position is ideal for anyone with 2+ years of experience working in Cleaning validation in a Fill Finish environment.
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Key responsibilities:
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* Design, Author, Review and Approve qualification/validation documentation and cycle development studies in line with the standard approval process.
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* Resolving technical issues encountered during study execution.
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* Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
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* Support continuous improvement through Lean Six Sigma methodologies.
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Requirements:
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To succeed in this role, you should have considerable experience in a comparable role, with experience operating as an individual contributor adding value to the business in a GMP manufacturing setting.
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The successful candidate will also have relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, along with demonstratable experience of leading technical related projects.
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Preferred skills and qualifications:
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Bachelor's degree in a relevant field.
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Minimum 2+ years of experience in cleaning validation including CD & PQ of mobile vessels (CIP) and parts washers (COP).
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Experience in recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.
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Exception / Deviation Management and Change Control.
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Equipment and process validation, Sterile Fill-Finish processes and equipment.
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