Engineering and Technical Services
Our engineering and technical services group include facility startup and equipment shakedown support, commissioning and plant support, as well as helping organizations in implementation of engineering change management (ECM) throughout the lifecycle that fosters innovations and continual improvement.
Our engineering consultants are trained on the good engineering practices and ASTM E2500 streamlined documentation and verification approach enabling our engineers to focus on process improvements and what’s critical to process. From start to finish, our highest standards adhere to product safety. All the while, the utmost importance is given to personnel and environmental safety and is practiced regularly.
” We are an ISO 9001 quality management system certified company and our commitment to maintaining the highest quality of work while reducing total project cost is engraved in our quality policy and everyday work with our customers.”
Areas
Aseptic Processing
- RABS / Isolators
- Clean Rooms
Upstream and Downstream Manufacturing
- Cell Culture
- Fermentation
- Harvest
- Media Systems
Downstream Manufacturing
- Purification
- Filtration
Fill and Finish
- Filling
- Lyophilization
- Packaging: Serialization
Technical Knowledge
- Production Systems
- Product Development
- Facilities and Equipment
- Information Systems
- Supply Chain Management
- Quality Systems
- Regulatory Compliance
- P&IDs and PFDs
- Evaluation, Inspection, Maintenance, Design, Analysis, and Improvement of Various Equipment, either Electrical or Mechanical
- Performance of Extensive and Complex Repairs on Existing Equipment
- Equipment Procurement and Specification Development
Leadership and Professionalism
Demonstrate cost effective, risk-based approach
Practice time-management
Collaborator with various roles and disciplines, both internal and external
Excellent written and verbal communication skills
Engineering Support
Facilities Startup
Equipment Shakedown
P&ID Walkdown
Process Optimization
Mechanical & Controls Commissioning
Equipment Selection & Scale-up
Commissioning & Qualification
Integrated Commissioning & Qualification (ASTM E2500-13)
New Facility / Expansion
Aseptic / Sterile Processing and Clean Room
USP Grade Water systems, including WFI and more
Compressed Gases, i.e., Clean Air, Nitrogen
New Equipment