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Set standard for vison of platform, standards of engineering, and define a multi-year roadmap
Create engineering templates and playbooks for platform process descriptions, P&ID standards, utility requirements, and manufacturing technology standards
Set the design principles for facility interfaces (cleanroom and HVAC for example) that enable platform technologies
Set enterprise standards and adoption plans for end‑to‑end processing, including facility design requirements and utility infrastructure
Collaborate with CMC, Clinical, Regulatory, QA, Facilities Engineering, Project Engineering, and site leaders on process risk, equipment selection, facility design, and lifecycle strategies
Lead site technology transfers, facility‑fit assessments, utility definition, equipment installation and qualification protocols, and adoption of digital monitoring/decision tools
Requirements
10-13+ years in biologics manufacturing
Strong background in process engineering or facilities engineering
B.S. or M.S. in Chemical Engineering, Mechanical Engineering, or related field
7+ years in Process Engineering/Development with facility design exposure
late stage and commercial Pharma experience
Demonstrated experience in process scale up, equipment specification and selection, P&ID development, mass/energy balance calculations, and facility design for biologics manufacturing
Experience with cleanroom design, utility systems (WFI, clean steam, HVAC), material flow optimization, and equipment layout for GMP