Staff Augmentation Services - Engineering
Pharma-Tech Process and Facilities Services, LLC provides engineering technical support services in support of virtually all aspects of biopharmaceutical manufacturing operations. Our project management and technical service personnel can identify efficiencies and engineering resource strategies to streamline engineering objectives with a thorough understanding of engineering best practices and deep cross-functional understanding of complex biopharmaceutical manufacturing operations and quality systems. We specialize in project execution planning and implementation strategies for the technology transfer of traditional stainless steel unit operations consisting of P&IDs, Clean in Place and Steam Sterilization to the new world of single-use disposable technology with PFD’s, BOMs, gamma irradiation and leachable/extractables.
Pharma-Tech Engineering capabilities include:
- Process and Facility Engineering and Technology
- MEP and Critical Utility Engineering and Technology
- Engineering Subject Matter Expertise
- Project Management Best Practices
- Engineering Best Practices
- Cross-Functional Communication
- Process Architecture
- Systems, Equipment and Automation Engineering
- Lean Project Delivery
- Organizational Development
- Operational Excellence
- Information Technology
- Owners Representation and oversight
- Technology Evaluation
- Aseptic Processing
- Cell Culture and Upstream Processing
- Purification and Downstream Processing
- Formulation and Fill Finish
- Technical Writing
- Design of Experiments
- Technology Transfer
- Feasibility Studies
- Conceptual Design
- Detailed Design
- Value Engineering
- Modular Design
- P&IDs, PFDs, DCFDs, Plan Drawings
- As-Built Documentation
- Closure Documentation
- Electronic Turnover Packages (ETOP)
- Engineering Specifications
- Engineering Evaluation
- Engineering Test Plans
- Start-Up and Commissioning
- Decommissioning
- Factory Acceptance Testing
- Site Acceptance Testing
- 3rd Party Inspection and Verification
- Manufacturing Support
- Equipment Ownership
- Change Control and Management
- Special Projects
- Cleaning Strategies and Cycle Development CIP/COP
- Sterilization Strategies and Cycle Development SIP/Autoclaves
- Single-Use Disposable Technology
- Work Orders
- Bill of Materials
- Project Specifications
- Design Specifications
- Material Specifications
- Batch Records
- Production Troubleshooting
- Rouge mitigation and passivation
- Cross-Functional Communication
- Criticality and Impact Assessment
- Risk Assessment and Mitigation
- FDA 483 and Warning Letter Remediation
- LEED
- Drafting/CAD
- HAZOP Review
- ASTM 2500
- BPE 2009
- Basis of Design (BOD)
- Design Qualification
- User Requirements Specifications
- Functional Requirements Specification
- Operational Position Statements
- Preventative Maintenance
- Standard Operating Procedures (SOPs) and Guidelines
- Cleanroom Operations
- Cleanroom Containment Solutions
- Cleanroom Engineering Technician
- On call support
- Training