PDS is a trusted partner providing clients expertise in:

  • Process Engineering
  • Automation
  • Engineering Knowledge Management
  • Project Management
  • Program Management
  • Single-Use & Material Qualification

Process engineering in all phases for new, existing and multi-product facilities.

  • Front End Engineering Design (FEED)
  • Conceptual, Basic, & Detail Design
  • Tech Transfer & Facility Fit
  • Process Optimization
  • Engineering Project Support

Automation engineering in all phases for new, existing and multi-product facilities.

  • Control System Conceptual Design
  • Control System Specification, Design, & Implementation
  • Test-bed Development & Implementation
  • Computerized Systems Validation
  • Alarm Design & Rationalization

Driving greater efficiency for our clients in how they manage and generate engineering deliverables to support operations and engineering change management.

  • Facility Fit Assessments
  • Design Reviews
  • Risk Assessments
  • Process Description

Project controls to effectively manage their critical projects from conception through closure.

PDS partners both with clients and third party Providers to effectively manage project teams and project controls.

Our client’s projects range in scope and complexity however we treat each project by listening, planning, and delivering what is expected.

All phases of planning and implementing ASTM E2500 to manage all elements of the engineering and operational phases of the manufacturing system lifecycle and QbD.

  • ASTM E2500 Planning & Implementation
  • QRM Program Development & Implementation
  • Change Management
  • Design Review & Risk Assessment
  • QRM Consulting and Training

All single-use and material qualification activities.

  • Single-Use Program Development & Implementation
  • Requirements & Specifications
  • Leachables & Extractables Assessments
  • Component Failure Evaluation & Risk Assessment
  • Material Qualification Consulting & Training

Listen. Plan. Deliver. Success By Design.



Core Values

We partner with our clients as a trusted adviser to provide the highest possible value. Our core values are: Listen. Plan. Deliver.



Process Design Solutions mission is to provide state of the art, best in class, process engineering solutions to the biotech, pharmaceutical and medical device industries.



By appropriately applying the concepts and principles that support QbD in the engineering phase, we guide our clients toward improving all aspects of their engineering function, strategically focusing design efforts on product quality and patient safety.