Process and Project Engineering

Engineering to support Conceptual Design through Detailed Design, Construction, as well as Full Commissioning & Qualification. Utilizing both in-house resources and strategic partnerships, we offer the full gamut of engineering services (Process, Architectural, Mechanical, Electrical, Instrumentation/Controls, Civil/Structural, and Environmental)

Services Include

  • Facility fit analysis and siting/location due diligence support
  • GMP facility architectural layout design and personnel, material, and waste flows
  • GMP laboratory layout and design
  • Grade A - D GMP space design (clean rooms)
  • GMP HVAC air cascade and dP design
  • Feasibility studies / conceptual design
  • Detailed design and equipment specification including:
    • generation of piping & instrumentation diagrams (P&IDs)
    • equipment and instrumentation specifications
    • equipment and instrumentation data sheets
    • computer-aided design (CAD)
    • operational procedures
    • preventative maintenance (PM) plans
    • spare parts assessments
  • Procurement support and expediting
  • Factory or site acceptance testing for equipment
  • Construction coordination and management
  • Risk-based Commissioning & Qualification (C&Q)
  • Existing process scale-up
  • Existing process optimization using Six Sigma
  • Process development support, including:
    • mass balances & process flow diagrams (PFDs)
    • testing protocols
    • data collection and laboratory analysis

Representative Projects

  • Complete pilot and full-scale pharma manufacturing facility build-out
  • Expansion and renovations of microbial/ mammalian and cell/gene therapy biotech manufacturing facilities
  • Oral solid dosage manufacturing & packaging facility renovations
  • Detailed design of specialized pharmaceutical equipment, including reactors, filters, TFF skids, chromatography columns, dryers, and fill/finish equipment
  • Process clean utility systems (USP PW, WFI, Clean Steam, Process Air, Vacuum)
  • Other Process Utilities (Steam, Chilled Water, Heating Hot Oil, Dust Collection)
  • Laboratory and office space build-outs
  • CO2 capture from electrical plant stack emissions
  • Wastewater treatment plant upgrades