C&Q Lead Fill & Finish
(m/f/d)
Freelance/temporary employment for a project Stein Start date: asap Reference number: 839236/1
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Responsibilities
Lead and coordinate CQ execution for Fill and Finish facility systemsManage commissioning activities for filling, semi-stoppering, isolators, lyophilizers, and stopper treatment stationsEnsure alignment with C&Q and Validation Plans throughout project lifecycleDevelop and maintain commissioning schedules and test specificationsCollaborate with EPC teams, Engineering, Operations, and external vendorsSupport updates to Master C&Q Plan and related documentationOversee HVAC systems, H2O2 decontamination processes, and glove integrity testingCoordinate with construction and other disciplines (HSE, Automation, Electrical, etc.)Ensure proper documentation and execution of commissioning protocolsMonitor and report progress, risks, and mitigation strategies Profile
Experience in CQ for Fill and Finish and related utilitiesDiploma or higher degree in Mechanical or Chemical Engineering preferredProven expertise in liquid and lyophilized vial filling technologiesStrong understanding of cGMP and contract manufacturing environmentsExperience in project planning, resource estimation, and cost controlPrior roles as CQV Lead and/or Project ManagerHands-on field CQV execution experienceExcellent interpersonal and communication skillsFluent in English (written and spoken); German is a plusFamiliarity with Kneat for documentation (preferred but not mandatory) Benefits
Opportunity to lead critical CQ activities in a high-impact projectWork in a dynamic, cross-functional team environmentExposure to cutting-edge pharmaceutical manufacturing technologiesCompetitive compensation and project-based incentives