Responsible Engineer - Denmark, Copenhagen - 12 Month ContractOur client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Responsible Engineer to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry. Main ResponsibilitiesProvide technical support and troubleshooting for CIP processes/System - Specialist level. Manage, provide direction and ensuring a floorless corporation with engineering providers, vendors, project disciplines and User teams. Writing /reviewing technical documentation, and validation material.
Challenge technical changes and ensure best possible solutions are approved and implemented. Participate in project meetings managed by General Contractor and Subcontractors. Supervise equipment Installation in collaboration with the clients commissioning (CQV) team. Act as Engineering SME you will be managing deliverables from the engineering partners and vendors, answering requests from internal and external stakeholders, and reviewing process documentation, equipment specifications and other engineering stuff. Scoping and implementation of equipment modification and drive changes including risk assessmentsReview validation protocols and support commissioning and validation testing. Perform training to ensure the production teams understand equipment functionality.
Experience Required;Solid technical background and experience within CIP Equipment and processes. Requires extensive experience in the areas of GMP manufacturing, engineering, or facilities in a pharmaceutical environment. Fluent in English both verbal and written. If this role is of interest, please apply now!
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