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Cqv engineer

Next Generation
Cqv engineer
Posted: 9 December
Offer description

CQV EngineerMultiple LTD Contractor Roles Across Different Project AreasLocation:DublinContract Type:LTD ContractI am partnering with a leading pharmaceutical client who is expanding their CQV team and now seeking several experienced Contractors across Clean Utilities, Formulation and Component Prep and DPSL equipment. These roles are onsite and ideal for candidates with strong sterile drug product CQV backgrounds who enjoy delivering high quality commissioning, qualification and validation in a fast moving project environment.Clean Utilities C&Q EngineerResponsibilitiesDevelop and execute CQV documentation for Clean UtilitiesSupport project deliverables for safety, CQV schedule and documentation qualityEnsure GMP and utility systems comply with EU and FDA standardsManage deviations for assigned utilities and equipmentIdentify and mitigate qualification risksExecute FAT testing and integrate results into qualification activitiesComplete all mandatory site trainingRequirementsExperience with high purity water systems such as Purified Water, WFI, Clean Steam and High Purity GasesProven CQV lifecycle experience from design to handoverStrong documentation and planning skillsExcellent communication and teamworkExperience with digital validation platforms desirableDegree in science or engineering plus 5 or more years CQV experienceCQV Engineer Formulation and Component PrepResponsibilitiesDevelop and execute CQV documentation for formulation and component prep equipmentDeliver project milestones across safety, schedule and documentation qualityEnsure GMP and non GMP equipment meet regulatory and commissioning standardsManage deviations and perform risk assessmentsExecute FAT activities and incorporate results into qualificationMeet all training and compliance expectationsRequirementsExperience with sterile drug product equipmentExperience with Single Use Mixers, TCUs, Utility Panels, Filtration Systems, Autoclaves, Parts Washers, Blenders and Jet MillsStrong document preparation and execution skillsExcellent communicator with strong cross functional collaborationDegree in science or engineering plus 5 or more years CQV experienceCQV Engineer DPSLResponsibilitiesDevelop and execute CQV documentation for benchtop, mobile and analytical equipment including PAT tools, incubators, BSCs and TCUsDeliver on safety, schedule and documentation qualityEnsure GMP equipment meets internal and regulatory standardsManage deviations and support risk mitigationExecute FAT testing and integrate learnings into qualificationComplete required training in line with site metricsRequirementsExperience commissioning and qualifying small scale sterile equipmentStrong CQV lifecycle experienceExcellent documentation and planning capabilityExperience with ValGenesis or Kneat desirableDegree in science or engineering plus 3 to 5 years pharmaceutical CQV experienceNext StepsShould this position be of interest to you please submit your CV to Jessica using the apply button.Next Generation will never share your data outside of our organisation without your prior written consent.Please read our Data Protection Policy on our website.If you require any reasonable accommodations during the recruitment process please let us know and we will do our best to support you.

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