Steve Waxmonsky

Engineering Consultant

  • Project Management
  • Process Design
  • Control System Design
  • Process Evaluation
  • Validation

Experience

Over 25 years delivering project and process support to pharmaceutical and chemical manufacturing facilities.

Practical, hands-on background ensuring safety and functionality while working within customer specifications, regulatory requirements, and budgetary constraints.

Innovative and proactive appoach to engineering, deploying, and implementing effective and efficient solutions.

Services

Project Management

  • Client Representative
  • Contractor Management
  • Tender Package Preparation
  • Technology Transfer
  • Startup and Commissioning

Process Design

  • Equipment Selection
  • Component Specification
  • System Documentation

Control System Design

  • P&IDs
  • Control Scheme Development
  • PLC Programming

Process Evaluation

  • Risk Assessments
  • Process Improvements
  • Hazard Reviews
  • Fault Finding
  • Quality Investigations
  • Root Cause Analysis

Validation

  • System Documentation
    • User Requirements Specifications
    • Functional Specifications
  • Equipment Validation (Development and Execution)
    • Installation Qualification
    • Operational Qualification
    • Performance Qualification
  • Process Validation

Projects

New Facility Equipment Validation Protocol Development and Execution
Purified Water Generation System Installation
Compounding Tank Heating and Cooling System Design
Liquid Pharmaceutical Product Technology Transfer
Laboratory Construction Management
Clean Room Air Handler Replacement
Bottle Capping Machine Purchase and Installation
Suppository Machine Purchase and Installation
Flammable Liquids Handling Process Train Design and Installation
Hydrogenation and Adsorption Process Scale-up
Process Waste Water Treatment Technology Selection and Project Management
Ammonia Monitoring System Design and Installation