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Process specialist - drug product msat

Basel
Gi Group
Inserat online seit: Veröffentlicht vor 4 Std.
Beschreibung

PpWe are seeking a highly motivated technical professional with a degree in Chemical or Biochemical Engineering (or related discipline) and at least three years of relevant industrial experience in platform-specific process development, process engineering, or manufacturing operations (e.g., DS Biologics, DP Small Molecules). The role requires strong technical expertise, regulatory awareness, and excellent communication skills to support product industrialization and lifecycle management. /ppContract: 6 months (extension verxy likely) /ppLocation: Basel /ph3Tasks Responsibilities /h3ulliSupport Product Technical Leads and Product Stewards in process industrialization, including facility fit, manufacturability, and PPQ support as needed /liliCoordinate and execute process gap assessments, integrate risks into risk logs, and drive mitigation strategies /liliDrive continuous technical product health, supply improvements, and second-source or change-source strategies /liliProvide technical expertise for technical, engineering, and validation runs, internally and externally /liliDeliver second-level commercial product support, including investigations, troubleshooting, and CAPA execution across the manufacturing network /liliLead non-product-specific RCAs and investigations on behalf of the manufacturing network /liliSupport validated state activities (e.g., WCB shipments, special sampling, additional studies) and ensure compliance /liliLeverage pilot plant capabilities for scaled experimentation, validation studies, and technology transfer /liliImplement network initiatives aligned with manufacturing site plans and portfolio-wide requirements /liliPerform technical product lifecycle activities and execute process-related complaint mitigation and CAPA deployment /liliDrive technical sustainability and digital advancement initiatives /liliCollaborate closely with global, site, and external partners, and act as a digital enabler by translating business needs into digital solutions /li /ulh3Requirements /h3ulliB.S. or M.S. in Chemical Engineering, Biochemical Engineering, or related field; PhD is an advantage /liliMinimum 3 years of industrial experience in process engineering, technical process development, validation, or technology transfer /liliStrong knowledge of pharmaceutical quality systems, regulatory expectations, and health authority requirements /liliExpertise with platform-specific technologies, processes, and equipment /liliExcellent written and verbal communication skills, including interaction with senior leadership /liliFluency in English required; German is an advantage /li /ul /p #J-18808-Ljbffr

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