Project Engineering

Axiom Project Engineering provides a perspective on projects with regard to design standards, constructability, and meeting requirements for life sciences facilities and processes. Our project engineers have a broad and diverse understanding of multiple technical disciplines associated with life sciences projects. While working within cross-functional teams, the project engineer will review facility and process requirements, while taking into consideration established standards and design criteria. Project Engineering services run through each phase of the project lifecycle, in addition to supporting manufacturing operations.

With a wide range of specialties in Active Pharmaceutical Ingredients or Drug Substance, Bulk Intermediates, OTC, Solid, and Liquid Dosage Forms, Biotechnology / Biologics, Nutraceuticals, Pharmaceuticals, Parentals, Clinical Manufacturing, Finishing / Packaging, Cosmetics, and Medical Devices, the following aspects are supported by Axiom Project Engineering:

Up Front Engineering

  • Feasibility
  • Detailed Design and Review
  • Software/Automation Design and Review or Forensics

Field Testing and Troubleshooting

  • FAT and SAT Support

Construction

  • Construction Management Support
  • Field Inspections
  • Drawing Redlines

Manufacturing Operations

  • Preventative Maintenance Program
  • cGMP Facilities Engineering
  • Manufacturing Investigation Reports
  • Planned Shutdown Coordination
  • Standard Operating Procedure Authoring

Automation and Infrastructure Management

  • IT Network Infrastructure
  • Electronic Records Storage Transmittal
  • Building Automation Systems
  • Laboratory Information Management System
  • Programmable Logic Controllers, SCADA, Delta V, and Siemens Systems

Process Engineering

  • Process Flow and Design
  • Process Optimization
  • Material and Personnel Flow

We Are Highly Skilled In the Project Engineering and Compliance Standards of:

  • ISO- International Organization for Standardization
  • GCP- Good Clinical Practice
  • GxP- Good Practice guidelines & regulations
  • ASTM- American Society for Testing and Materials
  • Allen Bradley
  • SCADA- Supervisory Control and Data Acquisition
  • PLC- Programmable Logic Controller
  • cGMP Projects- Current Good Manufacturing Practices
  • cGLP Projects- Current Good Laboratory Practices
  • ASTM e2500
  • 21 CFR Part 11
  • GAMP- Good Automated Manufacturing Practice
  • Delta V

See our other services for program management, qualification & validation, regulatory & quality, and strategic sourcing.

To learn more about our project engineering, please contact us to discuss your projects with an Axiom subject matter expert today.