QA Cleaning Validation
Independent Solutions
Limerick
Job Summary & ResponsibilitiesCompletes documentationfor executionof cleaning validation qualificationsstudies and investigations. DocumentPreparation and report generation for activities for the Cleaning Validation Program onsite at the Limerick BioTech facility. Team Member positions to be filledin the following areas: Cleaning Validation. Taking Cleaning Validationsamples alongside Upstream/Downstream processing. Working closely withmanufacturing to ensure the CIP/SIP and dirty holds are to the correct timesand samples are taken. Shows focus & a consistenceapproach to the role and tasks. Excellent people skills. Experience in aseptictechnique. Experience in Gowning forIOS7/ISO8. Generating and ExecutingValidation Protocols. Actively look for Continuousimprovements. Experience in Validationspecifically cleaning validation. Experience in assessment ofcleaning issues during study runs, Experienced Technical writer, Experience inDeviation/Change control writing, Capable of managing a largeprogram, so project management skills would be necessary, An excellent understanding ofhow manufacturing/Cleaning Validation/Cleaning equipment works. Understanding of baselinestudies for new equipment. Experienced in coveragetesting and clean-into-service. Generate/review/Approval ofCV protocols, Generate Reports. Maintain and update CleaningValidation Plan. Schedule of cleaningactivities with Manufacturing. Liaise with numerousdepartments. Ensure Training is maintainedand current. Follow all EHS/Safety SOP/Policies. Proven Biotechexperience in the given area, as follows: Validationengineer position: 3-5 years Biotech cleaning validation experience. Experiencein Document Preparation and Execution. Experiencein major start-ups where clean-into-service, coverage testing, baseline studiesin commissioning area, and cleaning validation studies may be concurrentactivities in different trains. Goodtechnical knowledge of BioTech equipment and the concepts of BioTechmanufacturing. Have Troubleshooting and analytical mindset. This job originally appeared on RecruitIreland.com.
2132 days ago