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Director, Platform Technology & Operations

United States, Gaithersburg Employment contract 175000.00 - 250000.00 USD / Year · Job Posted May 29, 2026
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Job Responsibility

  • 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

What we offer

  • Cigna Medical
  • Cigna Dental
  • Vision
  • 401k w/ ADP
  • PTO
  • paid holidays
  • Sick Leave as required by law

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